Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-01-05 @ 6:08 PM
Study NCT ID:
NCT03687957
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-25
First Post:
2018-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
rhIL-7-hyFc on Increasing Lymphocyte Counts in Patients With Newly Diagnosed Non-severe Lymphopenic Gliomas Following Radiation and Temozolomide
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-11-13', 'type': 'ESTIMATED'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D005910', 'term': 'Glioma'}], 'ancestors': [{'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000712767', 'term': 'efineptakin alfa'}, {'id': 'D000077204', 'term': 'Temozolomide'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D003606', 'term': 'Dacarbazine'}, {'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mchheda@wustl.edu', 'phone': '314-747-2712', 'title': 'Dr. Milan Chheda', 'organization': 'Washington University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'After completion of enrollment to the Phase I and Phase II Randomized portions of the trial, funding was depleted. Despite numerous attempts to gain new funding, the Phase II Expansion portion of the trial was never opened to enrollment. The results are late due to this reason.'}}, 'adverseEventsModule': {'timeFrame': '- Serious adverse events and adverse events were collected from start of treatment through 30 days after end of treatment (median length of follow-up 215 days, full length 28-493 days). - All cause mortality is collected from enrollment date until 5 years following end of study treatment (median length of follow-up 561.5 days, full length 1-2271 days). 5 participants are still in follow-up for all-cause mortality.', 'eventGroups': [{'id': 'EG000', 'title': 'Phase I: rhIL-7-hyFc Dose Level 1 (60 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Phase I: rhIL-7-hyFc Dose Level 2 (120 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Phase I: rhIL-7-hyFc Dose Level 3 (240 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Phase I: rhIL-7-hyFc Dose Level 4 (540 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 5, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'Phase I: rhIL-7-hyFc Dose Level 5 (720 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 5, 'seriousNumAffected': 4}, {'id': 'EG005', 'title': 'Phase I: rhIL-7-hyFc Dose Level 6 (960 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 2, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'Randomized Phase II: Placebo', 'description': '-Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. Placebo will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of placebo injections are planned.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 9, 'seriousNumAtRisk': 11, 'deathsNumAffected': 9, 'seriousNumAffected': 3}, {'id': 'EG007', 'title': 'Randomized Phase II: rhIL-7-hyFc', 'description': 'Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'deathsNumAffected': 10, 'seriousNumAffected': 4}, {'id': 'EG008', 'title': 'Randomized Phase II: Not Randomized', 'description': 'Enrolled to Randomized Phase II trial portion but not randomized.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Hearing impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Fecal incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Injection site reaction', 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'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'COVID-19 infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Car accident injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Spinal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Generalized muscle weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Muscle weakness lower limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Muscle weakness right-sided', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Phase I Only: Safety and Tolerability of rhIL-7-hyFc as Measured by the Maximum Tolerated Dose (MTD) of rhIL-7-hyFc', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I: rhIL-7-hyFc All Dose Levels', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels'}], 'classes': [{'categories': [{'measurements': [{'value': '720', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 30 days of treatment start', 'description': '-The maximum tolerated dose (MTD) is defined as the dose level immediately below the non-tolerated dose. A total of at least 6 patients must be treated at a dose level for it to be considered the MTD.', 'unitOfMeasure': 'mcg/kg', 'reportingStatus': 'POSTED', 'populationDescription': 'All Phase I participants are evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Phase I: Safety and Tolerability of rhIL-7-hyFc as Measured by Number of Participants With Dose-limiting Toxicities (DLTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I: rhIL-7-hyFc Dose Level 1 (60 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels'}, {'id': 'OG001', 'title': 'Phase I: rhIL-7-hyFc Dose Level 2 (120 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels'}, {'id': 'OG002', 'title': 'Phase I: rhIL-7-hyFc Dose Level 3 (240 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels'}, {'id': 'OG003', 'title': 'Phase I: rhIL-7-hyFc Dose Level 4 (540 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels'}, {'id': 'OG004', 'title': 'Phase I: rhIL-7-hyFc Dose Level 5 (720 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels'}, {'id': 'OG005', 'title': 'Phase I: rhIL-7-hyFc Dose Level 6 (960 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels'}, {'id': 'OG006', 'title': 'Randomized Phase II: Placebo', 'description': '-Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. Placebo will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of placebo injections are planned.'}, {'id': 'OG007', 'title': 'Randomized Phase II: rhIL-7-hyFc', 'description': 'Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.'}, {'id': 'OG008', 'title': 'Randomized Phase II: Not Randomized', 'description': 'Enrolled to Randomized Phase II trial portion but not randomized.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 30 days of treatment start', 'description': '-DLTs are defined in the protocol.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure is for Phase I participants only.'}, {'type': 'PRIMARY', 'title': 'Randomized Phase II: Percent Change in Absolute Lymphocyte Count (ALC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I: rhIL-7-hyFc Dose Level 1 (60 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels'}, {'id': 'OG001', 'title': 'Phase I: rhIL-7-hyFc Dose Level 2 (120 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels'}, {'id': 'OG002', 'title': 'Phase I: rhIL-7-hyFc Dose Level 3 (240 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels'}, {'id': 'OG003', 'title': 'Phase I: rhIL-7-hyFc Dose Level 4 (540 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels'}, {'id': 'OG004', 'title': 'Phase I: rhIL-7-hyFc Dose Level 5 (720 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels'}, {'id': 'OG005', 'title': 'Phase I: rhIL-7-hyFc Dose Level 6 (960 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels'}, {'id': 'OG006', 'title': 'Randomized Phase II: Placebo', 'description': '-Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. Placebo will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of placebo injections are planned.'}, {'id': 'OG007', 'title': 'Randomized Phase II: rhIL-7-hyFc', 'description': 'Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.'}, {'id': 'OG008', 'title': 'Randomized Phase II: Not Randomized', 'description': 'Enrolled to Randomized Phase II trial portion but not randomized.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.66667', 'spread': '28.36597', 'groupId': 'OG006'}, {'value': '147.8261', 'spread': '285.9597', 'groupId': 'OG007'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Prior to adjuvant TMZ (approximately week 4)', 'description': 'Absolute lymphocyte count (ALC) is a laboratory test that measures the exact number of lymphocytes in a microliter (µL) of blood. Lymphocytes are a type of white blood cell that play a crucial role in the immune system.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants in the Randomized Phase II Placebo and Randomized Phase II rhIL-7-hyFc are evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Phase II Expansion Arm: Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II Expansion Arm: rhIL-7-hyFc', 'description': 'Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.'}], 'timeFrame': 'Through completion of follow-up (estimated to be 5 years and 6 months)', 'description': '-Defined from date of surgery to date of progression or death due to disease or date of last clinical follow up.', 'reportingStatus': 'POSTED', 'populationDescription': 'The Phase II Expansion Arm of the trial never opened to enrollment and no participants were enrolled.'}, {'type': 'SECONDARY', 'title': 'Phase I and Randomized Phase II: Immunogenicity as Measured by Anti-drug Antibodies (ADAs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I: rhIL-7-hyFc Dose Level 1 (60 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels'}, {'id': 'OG001', 'title': 'Phase I: rhIL-7-hyFc Dose Level 2 (120 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels'}, {'id': 'OG002', 'title': 'Phase I: rhIL-7-hyFc Dose Level 3 (240 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels'}, {'id': 'OG003', 'title': 'Phase I: rhIL-7-hyFc Dose Level 4 (540 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels'}, {'id': 'OG004', 'title': 'Phase I: rhIL-7-hyFc Dose Level 5 (720 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels'}, {'id': 'OG005', 'title': 'Phase I: rhIL-7-hyFc Dose Level 6 (960 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels'}, {'id': 'OG006', 'title': 'Randomized Phase II: Placebo', 'description': '-Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. Placebo will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of placebo injections are planned.'}, {'id': 'OG007', 'title': 'Randomized Phase II: rhIL-7-hyFc', 'description': 'Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.'}, {'id': 'OG008', 'title': 'Randomized Phase II: Not Randomized', 'description': 'Enrolled to Randomized Phase II trial portion but not randomized.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '11', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'categories': [{'title': 'Detected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}, {'title': 'Not Detected', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '10', 'groupId': 'OG007'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '7', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'categories': [{'title': 'Detected', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '7', 'groupId': 'OG007'}]}, {'title': 'Not Detected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'categories': [{'title': 'Detected', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}, {'title': 'Not Detected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Week 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'categories': [{'title': 'Detected', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}, {'title': 'Not Detected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 1, Week 13, Week 25, and Week 45', 'description': '* The formation of anti-drug antibodies (ADA) to rhIL-7-hyFc will be evaluated: BioAgilytix will perform both Elisa Binding (non-neutralizing) and neutralizing antibody assays according to their Standard Operating Procedure. The data will be presented if anti-drug antibodies are detected or not detected in the samples.\n* Week 1 will be prior to injection of 1st dose of rhIL-7-hyFc, week 13 will be prior to the 2nd dose of rhIL-7-hyFc, and week 45 will be 8 weeks after the last dose of rhIL-7-hyFc.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Samples were not collected at all time points if a participant was removed from treatment or removed from the study prior to that timepoint. Week 25 was removed with amendment #4 and only one participant had a sample collected at this time point.'}, {'type': 'SECONDARY', 'title': 'Phase I: Percent Change in Absolute Lymphocyte Count (ALC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I: rhIL-7-hyFc Dose Level 1 (60 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels'}, {'id': 'OG001', 'title': 'Phase I: rhIL-7-hyFc Dose Level 2 (120 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels'}, {'id': 'OG002', 'title': 'Phase I: rhIL-7-hyFc Dose Level 3 (240 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels'}, {'id': 'OG003', 'title': 'Phase I: rhIL-7-hyFc Dose Level 4 (540 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels'}, {'id': 'OG004', 'title': 'Phase I: rhIL-7-hyFc Dose Level 5 (720 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels'}, {'id': 'OG005', 'title': 'Phase I: rhIL-7-hyFc Dose Level 6 (960 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels'}, {'id': 'OG006', 'title': 'Randomized Phase II: Placebo', 'description': '-Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. Placebo will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of placebo injections are planned.'}, {'id': 'OG007', 'title': 'Randomized Phase II: rhIL-7-hyFc', 'description': 'Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.'}, {'id': 'OG008', 'title': 'Randomized Phase II: Not Randomized', 'description': 'Enrolled to Randomized Phase II trial portion but not randomized.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.5', 'spread': 'NA', 'comment': 'SD was not able to be calculated because data is for 1 participant', 'groupId': 'OG000'}, {'value': '-22.222', 'spread': 'NA', 'comment': 'SD was not able to be calculated because data is for 1 participant', 'groupId': 'OG001'}, {'value': '25', 'spread': '161.231', 'groupId': 'OG002'}, {'value': '129.545', 'spread': '81.696', 'groupId': 'OG003'}, {'value': '52.083', 'spread': '87.525', 'groupId': 'OG004'}, {'value': '-5.639', 'spread': '88.787', 'groupId': 'OG005'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Prior to adjuvant TMZ (approximately week 4)', 'description': 'Absolute lymphocyte count (ALC) is a laboratory test that measures the exact number of lymphocytes in a microliter (µL) of blood. Lymphocytes are a type of white blood cell that play a crucial role in the immune system.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only Phase I participants are evaluable for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase I: rhIL-7-hyFc Dose Level 1 (60 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels'}, {'id': 'FG001', 'title': 'Phase I: rhIL-7-hyFc Dose Level 2 (120 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels'}, {'id': 'FG002', 'title': 'Phase I: rhIL-7-hyFc Dose Level 3 (240 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels'}, {'id': 'FG003', 'title': 'Phase I: rhIL-7-hyFc Dose Level 4 (540 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels'}, {'id': 'FG004', 'title': 'Phase I: rhIL-7-hyFc Dose Level 5 (720 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels'}, {'id': 'FG005', 'title': 'Phase I: rhIL-7-hyFc Dose Level 6 (960 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels'}, {'id': 'FG006', 'title': 'Randomized Phase II: Placebo', 'description': '-Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. Placebo will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of placebo injections are planned.'}, {'id': 'FG007', 'title': 'Randomized Phase II: rhIL-7-hyFc', 'description': 'Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.'}, {'id': 'FG008', 'title': 'Randomized Phase II: Not Randomized', 'description': 'Enrolled to Randomized Phase II trial portion but not randomized.'}, {'id': 'FG009', 'title': 'Phase II Expansion Arm: rhIL-7-hyFc', 'description': 'Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '11'}, {'groupId': 'FG007', 'numSubjects': '11'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '5'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '7'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'New malignancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Patient went on hospice', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The Phase II Expansion Arm never opened to enrollment and no participants were enrolled in this portion of the trial.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}, {'value': '11', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '42', 'groupId': 'BG009'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase I: rhIL-7-hyFc Dose Level 1 (60 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels'}, {'id': 'BG001', 'title': 'Phase I: rhIL-7-hyFc Dose Level 2 (120 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels'}, {'id': 'BG002', 'title': 'Phase I: rhIL-7-hyFc Dose Level 3 (240 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels'}, {'id': 'BG003', 'title': 'Phase I: rhIL-7-hyFc Dose Level 4 (540 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels'}, {'id': 'BG004', 'title': 'Phase I: rhIL-7-hyFc Dose Level 5 (720 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels'}, {'id': 'BG005', 'title': 'Phase I: rhIL-7-hyFc Dose Level 6 (960 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels'}, {'id': 'BG006', 'title': 'Randomized Phase II: Placebo', 'description': '-Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. Placebo will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of placebo injections are planned.'}, {'id': 'BG007', 'title': 'Randomized Phase II: rhIL-7-hyFc', 'description': 'Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.'}, {'id': 'BG008', 'title': 'Randomized Phase II: Not Randomized', 'description': 'Enrolled to Randomized Phase II trial portion but not randomized.'}, {'id': 'BG009', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000', 'lowerLimit': '57', 'upperLimit': '57'}, {'value': '32', 'groupId': 'BG001', 'lowerLimit': '32', 'upperLimit': '32'}, {'value': '46', 'groupId': 'BG002', 'lowerLimit': '45', 'upperLimit': '66'}, {'value': '63', 'groupId': 'BG003', 'lowerLimit': '24', 'upperLimit': '67'}, {'value': '57.5', 'groupId': 'BG004', 'lowerLimit': '30', 'upperLimit': '77'}, {'value': '34', 'groupId': 'BG005', 'lowerLimit': '30', 'upperLimit': '38'}, {'value': '58', 'groupId': 'BG006', 'lowerLimit': '33', 'upperLimit': '74'}, {'value': '61', 'groupId': 'BG007', 'lowerLimit': '44', 'upperLimit': '74'}, {'value': '42', 'groupId': 'BG008', 'lowerLimit': '42', 'upperLimit': '42'}, {'value': '57.5', 'groupId': 'BG009', 'lowerLimit': '24', 'upperLimit': '77'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '15', 'groupId': 'BG009'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '27', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}, {'value': '11', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '41', 'groupId': 'BG009'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '39', 'groupId': 'BG009'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}, {'value': '11', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '42', 'groupId': 'BG009'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-05-15', 'size': 1238149, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-10-07T09:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Phase II only: This study is triple-blinded (participant, physician, and study coordinator are all blinded; pharmacist and study statistician are not blinded)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': '-Phase I enrollment will be a sequential enrollment (patients will be stratified by concomitant use of steroids (yes/no). Phase II randomized portion will open with 2 arms being enrolled to in parallel. Phase II expansion cohort will not be randomized.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-04-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2018-09-25', 'resultsFirstSubmitDate': '2025-10-30', 'studyFirstSubmitQcDate': '2018-09-25', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-13', 'studyFirstPostDateStruct': {'date': '2018-09-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase I Only: Safety and Tolerability of rhIL-7-hyFc as Measured by the Maximum Tolerated Dose (MTD) of rhIL-7-hyFc', 'timeFrame': 'Within 30 days of treatment start', 'description': '-The maximum tolerated dose (MTD) is defined as the dose level immediately below the non-tolerated dose. A total of at least 6 patients must be treated at a dose level for it to be considered the MTD.'}, {'measure': 'Phase I: Safety and Tolerability of rhIL-7-hyFc as Measured by Number of Participants With Dose-limiting Toxicities (DLTs)', 'timeFrame': 'Within 30 days of treatment start', 'description': '-DLTs are defined in the protocol.'}, {'measure': 'Randomized Phase II: Percent Change in Absolute Lymphocyte Count (ALC)', 'timeFrame': 'Baseline to Prior to adjuvant TMZ (approximately week 4)', 'description': 'Absolute lymphocyte count (ALC) is a laboratory test that measures the exact number of lymphocytes in a microliter (µL) of blood. Lymphocytes are a type of white blood cell that play a crucial role in the immune system.'}, {'measure': 'Phase II Expansion Arm: Progression-free Survival (PFS)', 'timeFrame': 'Through completion of follow-up (estimated to be 5 years and 6 months)', 'description': '-Defined from date of surgery to date of progression or death due to disease or date of last clinical follow up.'}], 'secondaryOutcomes': [{'measure': 'Phase I and Randomized Phase II: Immunogenicity as Measured by Anti-drug Antibodies (ADAs)', 'timeFrame': 'Week 1, Week 13, Week 25, and Week 45', 'description': '* The formation of anti-drug antibodies (ADA) to rhIL-7-hyFc will be evaluated: BioAgilytix will perform both Elisa Binding (non-neutralizing) and neutralizing antibody assays according to their Standard Operating Procedure. The data will be presented if anti-drug antibodies are detected or not detected in the samples.\n* Week 1 will be prior to injection of 1st dose of rhIL-7-hyFc, week 13 will be prior to the 2nd dose of rhIL-7-hyFc, and week 45 will be 8 weeks after the last dose of rhIL-7-hyFc.'}, {'measure': 'Phase I: Percent Change in Absolute Lymphocyte Count (ALC)', 'timeFrame': 'Baseline to Prior to adjuvant TMZ (approximately week 4)', 'description': 'Absolute lymphocyte count (ALC) is a laboratory test that measures the exact number of lymphocytes in a microliter (µL) of blood. Lymphocytes are a type of white blood cell that play a crucial role in the immune system.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glioma']}, 'referencesModule': {'references': [{'pmid': '35031547', 'type': 'DERIVED', 'citation': 'Campian JL, Ghosh S, Kapoor V, Yan R, Thotala S, Jash A, Hu T, Mahadevan A, Rifai K, Page L, Lee BH, Ferrando-Martinez S, Wolfarth AA, Yang SH, Hallahan D, Chheda MG, Thotala D. Long-Acting Recombinant Human Interleukin-7, NT-I7, Increases Cytotoxic CD8 T Cells and Enhances Survival in Mouse Glioma Models. Clin Cancer Res. 2022 Mar 15;28(6):1229-1239. doi: 10.1158/1078-0432.CCR-21-0947.'}], 'seeAlsoLinks': [{'url': 'http://siteman.wustl.edu', 'label': 'Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine'}]}, 'descriptionModule': {'briefSummary': 'The investigators have developed a phase I/II clinical trial to evaluate the effect of rhIL-7-hyFc on lymphocyte counts in patients with high grade glioma (HGG).\n\nA phase I study will test whether rhIL-7-hyFc can be safely administered to patients with HGG. Six doses of rhIL-7-hyFc will be tested using a mix of Accelerated Phase and standard 3+3 dose-escalation design. The phase II portion to test effect of rhIL-7-hyFc on lymphocyte counts will use placebo-controlled randomization in HGG patients whose treatment include the standard radiation therapy (RT) and temozolomide (TMZ).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* World Health Organization (WHO) grade III, grade IV, and high risk grade II gliomas that require RT and TMZ treatment.\n* Phase 2 Expansion Cohort ONLY: Must be IDH1 wildtype, as defined by negative immunohistochemistry using an R132H-specific antibody and MGMT promoter unmethylated glioblastoma multiforme (WHO grade IV).\n* Post-operative treatment must have included radiation and TMZ. Prior Gliadel Wafers are allowed. Glucocorticoid therapy is allowed. Tumor treating fields (TTF) device is allowed.\n* Adequate organ and marrow function defined as follows:\n\n * Absolute neutrophil count ≥ 1,000/mcL\n * Platelets ≥ 75,000/mcL\n * Hemoglobin ≥ 8 g/dL\n * Total bilirubin ≤ 3.0 x institutional upper limit of normal\n * AST (SGOT)/ALT (SGPT) ≤ 3.0 × institutional upper limit of normal\n * Absolute lymphocyte count (ALC) ≥ 600/mcL (required for phase I and randomized phase II only)\n* Karnofsky Performance Status (KPS) ≥ 60% (i.e. the patient must be able to care for himself/herself with occasional help from others).\n* Able to provide written informed consent (or consent from a legally authorized representative).\n* Women of childbearing potential must have a negative serum pregnancy test prior to study entry (within 14 days). Patients must be willing to be on adequate contraception during treatment.\n\n * 18 years of age.\n\nExclusion Criteria:\n\n* Receiving any other investigational agents which may affect patient's lymphocyte counts.\n* Pregnant women are excluded from this study because rhIL-7-hyFc has not been evaluated regarding its potential for teratogenic or abortifacients effects. There is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the study drug, breastfeeding should be discontinued if the mother is treated with rhIL-7-hyFc.\n* Has an active viral infection requiring systemic treatment at screening.\n* Has active autoimmune disease or syndrome (i.e. moderate or severe rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, myasthenia gravis, Guillain Barre syndrome, systemic lupus erythematosis, scleroderma, ulcerative colitis, Crohn's disease, autoimmune hepatitis, Wegener's etc.,) that requires systemic treatment at the time of screening. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Subjects are permitted to enroll if they have vitiligo, resolved childhood asthma/atopy, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.\n* Receipt of live attenuated vaccine within 30 days before the first dose of study treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guérin (BCG), Zoster, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. FluMist) are live attenuated vaccines and are not allowed.\n* Has clinically significant cardiac enzymes (\\[Tnl or TnT\\] or CK-MD)\n* Patients with a clinically significant EKG on screening triggering a echocardiogram which is also clinically significant"}, 'identificationModule': {'nctId': 'NCT03687957', 'briefTitle': 'rhIL-7-hyFc on Increasing Lymphocyte Counts in Patients With Newly Diagnosed Non-severe Lymphopenic Gliomas Following Radiation and Temozolomide', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Effect of rhIL-7-hyFc on Increasing Lymphocyte Counts in Patients With Newly Diagnosed Non-severe Lymphopenic Gliomas Following Radiation and Temozolomide', 'orgStudyIdInfo': {'id': '201810185'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase I: rhIL-7-hyFc Dose Level 1 (60 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels', 'interventionNames': ['Drug: rhIL-7-hyFc', 'Drug: Temozolomide', 'Radiation: Radiation therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Phase I: rhIL-7-hyFc Dose Level 2 (120 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels', 'interventionNames': ['Drug: rhIL-7-hyFc', 'Drug: Temozolomide', 'Radiation: Radiation therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Phase I: rhIL-7-hyFc Dose Level 3 (240 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels', 'interventionNames': ['Drug: rhIL-7-hyFc', 'Drug: Temozolomide', 'Radiation: Radiation therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Phase I: rhIL-7-hyFc Dose Level 4 (540 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels', 'interventionNames': ['Drug: rhIL-7-hyFc', 'Drug: Temozolomide', 'Radiation: Radiation therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Phase I: rhIL-7-hyFc Dose Level 5 (720 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels', 'interventionNames': ['Drug: rhIL-7-hyFc', 'Drug: Temozolomide', 'Radiation: Radiation therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Phase I: rhIL-7-hyFc Dose Level 6 (960 mcg/kg)', 'description': '* Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 7 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned\n* The phase I part will begin with an Accelerated Phase with 1 patient per cohort at the first 2 doses (60 mcg/kg and 120 mcg/kg) followed by a standard 3+3 design on the remaining 4 dose levels', 'interventionNames': ['Drug: rhIL-7-hyFc', 'Drug: Temozolomide', 'Radiation: Radiation therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Randomized Phase II: Placebo', 'description': '-Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. Placebo will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of placebo injections are planned.', 'interventionNames': ['Drug: Placebo', 'Drug: Temozolomide', 'Radiation: Radiation therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Randomized Phase II: rhIL-7-hyFc', 'description': 'Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.', 'interventionNames': ['Drug: rhIL-7-hyFc', 'Drug: Temozolomide', 'Radiation: Radiation therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Phase II Expansion Arm: rhIL-7-hyFc', 'description': 'Per standard treatment, patients will receive concurrent RT/TMZ followed by adjuvant TMZ on Days 1-5 of a 28-day cycle for a total of 6 cycles. rhIL-7hyFc will be given by intramuscular injection starting at the end of RT/TMZ (within 14 days after last day of RT/TMZ). The 2nd injection will be administered 3-5 days after the last dose of cycle 3 TMZ treatment (\\~week 13). The 3rd injection will be given 3-5 days after the last dose of cycle 6 TMZ treatment (\\~week 25). Note the 2nd and 3rd injections should be administered once between Day 3 through 5 following the last dose of TMZ to achieve the strongest response. The 4th injection (last injection in the study) will be given after completion of monthly TMZ (\\~Week 37). A total of 4 doses of rhIL-7-hyFc injections are planned.', 'interventionNames': ['Drug: rhIL-7-hyFc', 'Drug: Temozolomide', 'Radiation: Radiation therapy']}], 'interventions': [{'name': 'rhIL-7-hyFc', 'type': 'DRUG', 'description': '-Given by intramuscular injection', 'armGroupLabels': ['Phase I: rhIL-7-hyFc Dose Level 1 (60 mcg/kg)', 'Phase I: rhIL-7-hyFc Dose Level 2 (120 mcg/kg)', 'Phase I: rhIL-7-hyFc Dose Level 3 (240 mcg/kg)', 'Phase I: rhIL-7-hyFc Dose Level 4 (540 mcg/kg)', 'Phase I: rhIL-7-hyFc Dose Level 5 (720 mcg/kg)', 'Phase I: rhIL-7-hyFc Dose Level 6 (960 mcg/kg)', 'Phase II Expansion Arm: rhIL-7-hyFc', 'Randomized Phase II: rhIL-7-hyFc']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '-Given by intramuscular injection', 'armGroupLabels': ['Randomized Phase II: Placebo']}, {'name': 'Temozolomide', 'type': 'DRUG', 'otherNames': ['TMZ'], 'description': '-Standard of care', 'armGroupLabels': ['Phase I: rhIL-7-hyFc Dose Level 1 (60 mcg/kg)', 'Phase I: rhIL-7-hyFc Dose Level 2 (120 mcg/kg)', 'Phase I: rhIL-7-hyFc Dose Level 3 (240 mcg/kg)', 'Phase I: rhIL-7-hyFc Dose Level 4 (540 mcg/kg)', 'Phase I: rhIL-7-hyFc Dose Level 5 (720 mcg/kg)', 'Phase I: rhIL-7-hyFc Dose Level 6 (960 mcg/kg)', 'Phase II Expansion Arm: rhIL-7-hyFc', 'Randomized Phase II: Placebo', 'Randomized Phase II: rhIL-7-hyFc']}, {'name': 'Radiation therapy', 'type': 'RADIATION', 'otherNames': ['RT'], 'description': '-Standard of care', 'armGroupLabels': ['Phase I: rhIL-7-hyFc Dose Level 1 (60 mcg/kg)', 'Phase I: rhIL-7-hyFc Dose Level 2 (120 mcg/kg)', 'Phase I: rhIL-7-hyFc Dose Level 3 (240 mcg/kg)', 'Phase I: rhIL-7-hyFc Dose Level 4 (540 mcg/kg)', 'Phase I: rhIL-7-hyFc Dose Level 5 (720 mcg/kg)', 'Phase I: rhIL-7-hyFc Dose Level 6 (960 mcg/kg)', 'Phase II Expansion Arm: rhIL-7-hyFc', 'Randomized Phase II: Placebo', 'Randomized Phase II: rhIL-7-hyFc']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Milan Chheda, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'NeoImmuneTech', 'class': 'INDUSTRY'}, {'name': 'The Foundation for Barnes-Jewish Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}