Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT00873093
Status:
COMPLETED
Last Update Posted:
2017-01-27
First Post:
2009-03-31
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Bortezomib and Combination Chemotherapy in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001215', 'term': 'Asparaginase'}, {'id': 'C087753', 'term': 'palmitoyl-L-asparaginase'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D006854', 'term': 'Hydrocortisone'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D000069286', 'term': 'Bortezomib'}, {'id': 'C042705', 'term': 'pegaspargase'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'C015342', 'term': 'merphos'}, {'id': 'C061400', 'term': 'etoposide phosphate'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D000069585', 'term': 'Filgrastim'}, {'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D002955', 'term': 'Leucovorin'}], 'ancestors': [{'id': 'D000581', 'term': 'Amidohydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D015062', 'term': '11-Hydroxycorticosteroids'}, {'id': 'D006889', 'term': 'Hydroxycorticosteroids'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D015065', 'term': '17-Hydroxycorticosteroids'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D001897', 'term': 'Boronic Acids'}, {'id': 'D000148', 'term': 'Acids, Noncarboxylic'}, {'id': 'D000143', 'term': 'Acids'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D001896', 'term': 'Boron Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D003067', 'term': 'Coenzymes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'resultsreportingcoordinator@childrensoncologygroup.org', 'phone': '626-447-0064', 'title': 'Results Reporting Coordinator', 'organization': "Children's Oncology Group"}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs/CAeRs). AE field contains grade 3 \\& higher CTCAEs reported on study excluding reported SAEs. Analyses on outcomes was based on eligible \\& evaluable patients. Reported AEs should be enrolled eligible patient based, so numbers of participants in the two AE tables are larger.', 'eventGroups': [{'id': 'EG000', 'title': 'Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.', 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.', 'otherNumAtRisk': 61, 'otherNumAffected': 58, 'seriousNumAtRisk': 61, 'seriousNumAffected': 47}, {'id': 'EG002', 'title': 'Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.', 'otherNumAtRisk': 49, 'otherNumAffected': 44, 'seriousNumAtRisk': 49, 'seriousNumAffected': 40}, {'id': 'EG003', 'title': 'T-cell ALL (Chemotherapy)', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.', 'otherNumAtRisk': 22, 'otherNumAffected': 21, 'seriousNumAtRisk': 22, 'seriousNumAffected': 18}, {'id': 'EG004', 'title': 'T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.', 'otherNumAtRisk': 10, 'otherNumAffected': 9, 'seriousNumAtRisk': 10, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 47, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 29, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Blood and lymphatic system disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Anal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Anal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Gastric hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Gastrointestinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Hemorrhoidal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Proctitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Rectal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Rectal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Typhlitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 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3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Pulmonary edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Respiratory, thoracic and mediastinal disorders - Other, specify', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Stridor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Skin ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Toxic epidermal necrolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Capillary leak syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'CTCV4'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'CTCV4'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Second Complete Remission Rate at the End of Block 1 Reinduction Chemotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.'}, {'id': 'OG001', 'title': 'Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.'}, {'id': 'OG002', 'title': 'Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.'}, {'id': 'OG003', 'title': 'T-cell ALL (Chemotherapy)', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.'}, {'id': 'OG004', 'title': 'T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.2', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'The outcome is measured the end of Block 1 (Day 36 of Block 1) of re-induction therapy.', 'description': 'The percentage of eligible and evaluable patients who have achieved complete response at the end Block 1 of re-induction therapy.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis on this primary outcome is limited to pre-B ALL with age \\<= 21 years who relapsed \\< 36 months only (stratum 1 \\& 2) per protocol section 9.2.1.'}, {'type': 'PRIMARY', 'title': 'Event Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.'}, {'id': 'OG001', 'title': 'Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.'}, {'id': 'OG002', 'title': 'Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.'}, {'id': 'OG003', 'title': 'T-cell ALL (Chemotherapy)', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.'}, {'id': 'OG004', 'title': 'T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '68.5', 'groupId': 'OG001'}, {'value': '37.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 months after enrollment', 'description': 'Percentage of patients who were event free at 4 months', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis on this primary outcome is limited to pre-B ALL with age \\<= 21 years who relapsed \\< 36 months only (stratum 1 \\& 2) per protocol section 9.2.1.'}, {'type': 'PRIMARY', 'title': 'Toxic Death Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall', 'description': 'All enrolled eligible patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 months', 'description': 'The proportion of toxic death rate among all eligible patients.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The toxic death was monitored for all eligible patients. It was not compared between subgroups per protocol 9.3.2.'}, {'type': 'PRIMARY', 'title': 'Severe Adverse Events (SAE) Rate.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall', 'description': 'All enrolled eligible patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 months', 'description': 'The proportion of SAE rate among all eligible patients', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The SAE event was monitored for all eligible patients. It was not compared between subgroups per protocol 9.3.2.'}, {'type': 'SECONDARY', 'title': 'Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.'}, {'id': 'OG001', 'title': 'Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.'}, {'id': 'OG002', 'title': 'Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.'}, {'id': 'OG003', 'title': 'T-cell ALL (Chemotherapy)', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.'}, {'id': 'OG004', 'title': 'T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.4', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of Block 1 (Day 36 of Block 1) of re-induction therapy', 'description': 'Percentage of eligible and evaluable patients with MRD \\< 0.01% among those who had successful MRD determination at the end of Block 1.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The MRD analysis is limited to eligible and evaluable pre-B ALL with age \\<= 21 years who relapsed \\< 36 months only (stratum 1 \\& 2) and have successful MRD determination at the end of Block 1per protocol section 9.3.3.'}, {'type': 'SECONDARY', 'title': 'Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.'}, {'id': 'OG001', 'title': 'Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.'}, {'id': 'OG002', 'title': 'Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.'}, {'id': 'OG003', 'title': 'T-cell ALL (Chemotherapy)', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.'}, {'id': 'OG004', 'title': 'T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG001'}, {'value': '42.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of Block 2 (Day 36 of Block 2) of re-induction therapy', 'description': 'Percentage of eligible and evaluable patients with MRD \\< 0.01% among those who had successful MRD determination at the end of Block 2.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The MRD analysis is limited to eligible and evaluable pre-B ALL with age \\<= 21 years who relapsed \\< 36 months only (stratum 1 \\& 2) and have successful MRD determination at the end of Block 2per protocol section 9.3.3.'}, {'type': 'SECONDARY', 'title': 'Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.'}, {'id': 'OG001', 'title': 'Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.'}, {'id': 'OG002', 'title': 'Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.'}, {'id': 'OG003', 'title': 'T-cell ALL (Chemotherapy)', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.'}, {'id': 'OG004', 'title': 'T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'OG001'}, {'value': '63.6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of Block 3 (Day 36 of Block 3) of re-induction therapy', 'description': 'Percentage of eligible and evaluable patients with MRD \\< 0.01% among those who had successful MRD determination at the end of Block 3.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The MRD analysis is limited to eligible and evaluable pre-B ALL with age \\<= 21 years who relapsed \\< 36 months only (stratum 1 \\& 2) and have successful MRD determination at the end of Block 3per protocol section 9.3.3.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'NF-kB Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs', 'description': 'Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.\n\nL-asparaginase: Given IM 6000 IU/m2/dose Days 2 and 9\n\ndoxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1\n\ntherapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 \\& 29 Block 2: Days 1 \\& 22\n\nvincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22\n\ncytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 \\& 9\n\nprednisone: Given PO or IV 40 mg/m2/day on Days 1-28\n\nbortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 \\& 11 Block 2: Days 1, 4 \\& 8\n\npegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 \\& 22\n\nMTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 \\& 29 Block 2: Days 1 \\& 22\n\netopo'}, {'id': 'OG001', 'title': 'Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs', 'description': 'Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.\n\nL-asparaginase: Given IM 6000 IU/m2/dose Days 2 \\& 9\n\ndoxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1\n\ntherapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 \\& 29 Block 2: Days 1 \\& 22\n\nvincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 \\& 22\n\ncytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 \\& 9\n\nprednisone: Given PO or IV 40 mg/m2/day on Days 1-28\n\nbortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 \\& 11 Block 2: Days 1, 4 \\& 8\n\npegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 \\& 22\n\nMTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 \\& 29 Block 2: Days 1 \\& 22\n\netopo'}, {'id': 'OG002', 'title': 'Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs', 'description': 'Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine.\n\nL-asparaginase: Given IM 6000 IU/m2/dose Days 2 \\& 9\n\ndoxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1\n\ntherapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 \\& 29 Block 2: Days 1 \\& 22\n\nvincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 \\& 22\n\ncytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 \\& 9\n\nprednisone: Given PO or IV 40 mg/m2/day on Days 1-28\n\nbortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 \\& 11 Block 2: Days 1, 4 \\& 8\n\npegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 \\& 22\n\nMTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 \\& 29 Block 2: Days 1 \\& 22\n\netopo'}, {'id': 'OG003', 'title': 'T-cell ALL (Chemotherapy)', 'description': 'Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine.\n\nL-asparaginase: Given IM 6000 IU/m2/dose Days 2 \\& 9\n\ndoxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1\n\ntherapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 \\& 29 Block 2: Days 1 \\& 22\n\nvincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 \\& 22\n\ncytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 \\& 9\n\nprednisone: Given PO or IV 40 mg/m2/day on Days 1-28\n\nbortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 \\& 11 Block 2: Days 1, 4 \\& 8\n\npegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 \\& 22\n\nmethotrexate: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 \\& 29 Block 2: Days 1 \\& 22\n\netopo'}, {'id': 'OG004', 'title': 'T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)', 'description': 'Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.\n\nL-asparaginase: Given IM 6000 IU/m2/dose Days 2 \\& 9\n\ndoxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1\n\ntherapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 \\& 29 Block 2: Days 1 \\& 22\n\nvincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 \\& 22\n\ncytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 \\& 9\n\nprednisone: Given PO or IV 40 mg/m2/day on Days 1-28\n\nbortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 \\& 11 Block 2: Days 1, 4 \\& 8\n\npegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 \\& 22\n\nMTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 \\& 29 Block 2: Days 1 \\& 22\n\netopo'}], 'timeFrame': 'Up to 5 years', 'description': 'NF-kB activity will be measured as a continuous variable (ng NF-kB/ug protein). Differences in NF-kB activity between time points will be assessed using summary statistics such as mean, standard deviation, and range.', 'reportingStatus': 'POSTED', 'populationDescription': 'These were for correlative biology studies and the data were not collected in COG database.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Expression of Apoptotic and Cell Cycle Proteins Assessed by Using Gene and Tissue Microarrays and Immunoblots', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs', 'description': 'Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.\n\nL-asparaginase: Given IM 6000 IU/m2/dose Days 2 and 9\n\ndoxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1\n\ntherapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 \\& 29 Block 2: Days 1 \\& 22\n\nvincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22\n\ncytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 \\& 9\n\nprednisone: Given PO or IV 40 mg/m2/day on Days 1-28\n\nbortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 \\& 11 Block 2: Days 1, 4 \\& 8\n\npegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 \\& 22\n\nMTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 \\& 29 Block 2: Days 1 \\& 22\n\netopo'}, {'id': 'OG001', 'title': 'Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs', 'description': 'Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.\n\nL-asparaginase: Given IM 6000 IU/m2/dose Days 2 \\& 9\n\ndoxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1\n\ntherapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 \\& 29 Block 2: Days 1 \\& 22\n\nvincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 \\& 22\n\ncytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 \\& 9\n\nprednisone: Given PO or IV 40 mg/m2/day on Days 1-28\n\nbortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 \\& 11 Block 2: Days 1, 4 \\& 8\n\npegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 \\& 22\n\nMTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 \\& 29 Block 2: Days 1 \\& 22\n\netopo'}, {'id': 'OG002', 'title': 'Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs', 'description': 'Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.\n\nL-asparaginase: Given IM 6000 IU/m2/dose Days 2 \\& 9\n\ndoxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1\n\ntherapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 \\& 29 Block 2: Days 1 \\& 22\n\nvincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 \\& 22\n\ncytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 \\& 9\n\nprednisone: Given PO or IV 40 mg/m2/day on Days 1-28\n\nbortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 \\& 11 Block 2: Days 1, 4 \\& 8\n\npegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 \\& 22\n\nMTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 \\& 29 Block 2: Days 1 \\& 22\n\netopo'}, {'id': 'OG003', 'title': 'T-cell ALL (Chemotherapy)', 'description': 'Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.\n\nL-asparaginase: Given IM 6000 IU/m2/dose Days 2 \\& 9\n\ndoxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1\n\ntherapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 \\& 29 Block 2: Days 1 \\& 22\n\nvincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 \\& 22\n\ncytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 \\& 9\n\nprednisone: Given PO or IV 40 mg/m2/day on Days 1-28\n\nbortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 \\& 11 Block 2: Days 1, 4 \\& 8\n\npegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 \\& 22\n\nmethotrexate: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 \\& 29 Block 2: Days 1 \\& 22\n\netopo'}, {'id': 'OG004', 'title': 'T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)', 'description': 'Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.\n\nL-asparaginase: Given IM 6000 IU/m2/dose Days 2 \\& 9\n\ndoxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1\n\ntherapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 \\& 29 Block 2: Days 1 \\& 22\n\nvincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 \\& 22\n\ncytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 \\& 9\n\nprednisone: Given PO or IV 40 mg/m2/day on Days 1-28\n\nbortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 \\& 11 Block 2: Days 1, 4 \\& 8\n\npegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 \\& 22\n\nMTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 \\& 29 Block 2: Days 1 \\& 22\n\netopo'}], 'timeFrame': 'Up to 5 years', 'description': 'Characterized using descriptive statistics. If differences are noted between pre- and post-treatment protein expression, pairwise comparisons will be made using paired t-test or an equivalent nonparametric test. The normality assumption will be assessed on the log-transformed data prior to paired t-test evaluation.', 'reportingStatus': 'POSTED', 'populationDescription': 'These were for correlative biology studies and the data were not collected in COG database.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Stem Cell Percentage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs', 'description': 'Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.\n\nL-asparaginase: Given IM 6000 IU/m2/dose Days 2 and 9\n\ndoxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1\n\ntherapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 \\& 29 Block 2: Days 1 \\& 22\n\nvincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22\n\ncytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 \\& 9\n\nprednisone: Given PO or IV 40 mg/m2/day on Days 1-28\n\nbortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 \\& 11 Block 2: Days 1, 4 \\& 8\n\npegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 \\& 22\n\nMTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 \\& 29 Block 2: Days 1 \\& 22\n\netopo'}, {'id': 'OG001', 'title': 'Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs', 'description': 'Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.\n\nL-asparaginase: Given IM 6000 IU/m2/dose Days 2 \\& 9\n\ndoxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1\n\ntherapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 \\& 29 Block 2: Days 1 \\& 22\n\nvincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 \\& 22\n\ncytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 \\& 9\n\nprednisone: Given PO or IV 40 mg/m2/day on Days 1-28\n\nbortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 \\& 11 Block 2: Days 1, 4 \\& 8\n\npegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 \\& 22\n\nMTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 \\& 29 Block 2: Days 1 \\& 22\n\netopo'}, {'id': 'OG002', 'title': 'Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs', 'description': 'Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.\n\nL-asparaginase: Given IM 6000 IU/m2/dose Days 2 \\& 9\n\ndoxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1\n\ntherapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 \\& 29 Block 2: Days 1 \\& 22\n\nvincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 \\& 22\n\ncytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 \\& 9\n\nprednisone: Given PO or IV 40 mg/m2/day on Days 1-28\n\nbortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 \\& 11 Block 2: Days 1, 4 \\& 8\n\npegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 \\& 22\n\nMTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 \\& 29 Block 2: Days 1 \\& 22\n\netopo'}, {'id': 'OG003', 'title': 'T-cell ALL (Chemotherapy)', 'description': 'Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.\n\nL-asparaginase: Given IM 6000 IU/m2/dose Days 2 \\& 9\n\ndoxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1\n\ntherapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 \\& 29 Block 2: Days 1 \\& 22\n\nvincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 \\& 22\n\ncytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 \\& 9\n\nprednisone: Given PO or IV 40 mg/m2/day on Days 1-28\n\nbortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 \\& 11 Block 2: Days 1, 4 \\& 8\n\npegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 \\& 22\n\nmethotrexate: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 \\& 29 Block 2: Days 1 \\& 22\n\netopo'}, {'id': 'OG004', 'title': 'T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)', 'description': 'Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.\n\nL-asparaginase: Given IM 6000 IU/m2/dose Days 2 \\& 9\n\ndoxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1\n\ntherapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 \\& 29 Block 2: Days 1 \\& 22\n\nvincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 \\& 22\n\ncytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 \\& 9\n\nprednisone: Given PO or IV 40 mg/m2/day on Days 1-28\n\nbortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 \\& 11 Block 2: Days 1, 4 \\& 8\n\npegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 \\& 22\n\nMTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 \\& 29 Block 2: Days 1 \\& 22\n\netopo'}], 'timeFrame': 'Baseline to post-treatment with bortezomib', 'description': 'Will use descriptive statistics to assess mean +/- standard deviation for stem cell percentage before and after bortezomib treatment. If there appears to be a difference in responders vs. non-responders, stem cell percentage differences between responders and non-responders will be compared using a paired t-test or equivalent nonparametric test.', 'reportingStatus': 'POSTED', 'populationDescription': 'These were for correlative biology studies and the data were not collected in COG database.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Plasma Concentration-time Profiles', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs', 'description': 'Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.\n\nL-asparaginase: Given IM 6000 IU/m2/dose Days 2 and 9\n\ndoxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1\n\ntherapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 \\& 29 Block 2: Days 1 \\& 22\n\nvincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22\n\ncytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 \\& 9\n\nprednisone: Given PO or IV 40 mg/m2/day on Days 1-28\n\nbortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 \\& 11 Block 2: Days 1, 4 \\& 8\n\npegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 \\& 22\n\nMTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 \\& 29 Block 2: Days 1 \\& 22\n\netopo'}, {'id': 'OG001', 'title': 'Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs', 'description': 'Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.\n\nL-asparaginase: Given IM 6000 IU/m2/dose Days 2 \\& 9\n\ndoxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1\n\ntherapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 \\& 29 Block 2: Days 1 \\& 22\n\nvincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 \\& 22\n\ncytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 \\& 9\n\nprednisone: Given PO or IV 40 mg/m2/day on Days 1-28\n\nbortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 \\& 11 Block 2: Days 1, 4 \\& 8\n\npegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 \\& 22\n\nMTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 \\& 29 Block 2: Days 1 \\& 22\n\netopo'}, {'id': 'OG002', 'title': 'Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs', 'description': 'Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.\n\nL-asparaginase: Given IM 6000 IU/m2/dose Days 2 \\& 9\n\ndoxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1\n\ntherapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 \\& 29 Block 2: Days 1 \\& 22\n\nvincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 \\& 22\n\ncytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 \\& 9\n\nprednisone: Given PO or IV 40 mg/m2/day on Days 1-28\n\nbortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 \\& 11 Block 2: Days 1, 4 \\& 8\n\npegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 \\& 22\n\nMTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 \\& 29 Block 2: Days 1 \\& 22\n\netopo'}, {'id': 'OG003', 'title': 'T-cell ALL (Chemotherapy)', 'description': 'Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.\n\nL-asparaginase: Given IM 6000 IU/m2/dose Days 2 \\& 9\n\ndoxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1\n\ntherapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 \\& 29 Block 2: Days 1 \\& 22\n\nvincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 \\& 22\n\ncytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 \\& 9\n\nprednisone: Given PO or IV 40 mg/m2/day on Days 1-28\n\nbortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 \\& 11 Block 2: Days 1, 4 \\& 8\n\npegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 \\& 22\n\nmethotrexate: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 \\& 29 Block 2: Days 1 \\& 22\n\netopo'}, {'id': 'OG004', 'title': 'T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)', 'description': 'Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.\n\nL-asparaginase: Given IM 6000 IU/m2/dose Days 2 \\& 9\n\ndoxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1\n\ntherapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 \\& 29 Block 2: Days 1 \\& 22\n\nvincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 \\& 22\n\ncytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 \\& 9\n\nprednisone: Given PO or IV 40 mg/m2/day on Days 1-28\n\nbortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 \\& 11 Block 2: Days 1, 4 \\& 8\n\npegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 \\& 22\n\nMTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 \\& 29 Block 2: Days 1 \\& 22\n\netopo'}], 'timeFrame': 'Up to day 8 of block 2', 'description': 'Will be analyzed using descriptive statistics and will be graphically displayed by age group and stratum. PK data will be analyzed using methods such as nonlinear mixed effects modeling to estimate bortezomib clearance and volume of distribution (and the associated 95% confidence intervals) in each age group (2-11 years and 12-16 years of age).', 'reportingStatus': 'POSTED', 'populationDescription': 'These were for correlative biology studies and the data were not collected in COG database.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Pharmacokinetics (PK) of Bortezomib in Patients Receiving Multi-agent Combination Therapy.', 'timeFrame': 'Day 8 of blocks 1 and 2', 'description': 'This outcome measure cannot be reported due to the data used for analysis was not collected.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pre-B ALL Relapse<36 Mths From Diagnosis (Chemo) Age>21 yr', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.'}, {'id': 'FG001', 'title': 'Pre-B ALL Relapse 18-36 Mths From Diagnosis (Chemo) Age<=21 yr', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.'}, {'id': 'FG002', 'title': 'Pre-B ALL Relapse<18 Mths From Diagnosis (Chemo) Age<=21 Yrs', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.'}, {'id': 'FG003', 'title': 'T-cell ALL (Chemotherapy)', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.'}, {'id': 'FG004', 'title': 'T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '62'}, {'groupId': 'FG002', 'numSubjects': '49'}, {'groupId': 'FG003', 'numSubjects': '23'}, {'groupId': 'FG004', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '33'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '148', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.'}, {'id': 'BG001', 'title': 'Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.'}, {'id': 'BG002', 'title': 'Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.'}, {'id': 'BG003', 'title': 'T-cell ALL (Chemotherapy)', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.'}, {'id': 'BG004', 'title': 'T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)', 'description': 'Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 \\& 11 of Block 1 and days 1, 4, \\& 8 of Block 2.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '126', 'groupId': 'BG005'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}]}, {'title': '>=65 years', '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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '23.14', 'spread': '0.57', 'groupId': 'BG000'}, {'value': '10.16', 'spread': '5.77', 'groupId': 'BG001'}, {'value': '9.27', 'spread': '6.06', 'groupId': 'BG002'}, {'value': '13.00', 'spread': '5.28', 'groupId': 'BG003'}, {'value': '13.79', 'spread': '6.27', 'groupId': 'BG004'}, {'value': '10.91', 'spread': '6.23', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '63', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '85', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '38', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '107', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '104', 'groupId': 'BG005'}]}, {'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'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-30', 'studyFirstSubmitDate': '2009-03-31', 'resultsFirstSubmitDate': '2016-02-09', 'studyFirstSubmitQcDate': '2009-03-31', 'lastUpdatePostDateStruct': {'date': '2017-01-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-11-30', 'studyFirstPostDateStruct': {'date': '2009-04-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'NF-kB Activity', 'timeFrame': 'Up to 5 years', 'description': 'NF-kB activity will be measured as a continuous variable (ng NF-kB/ug protein). Differences in NF-kB activity between time points will be assessed using summary statistics such as mean, standard deviation, and range.'}, {'measure': 'Expression of Apoptotic and Cell Cycle Proteins Assessed by Using Gene and Tissue Microarrays and Immunoblots', 'timeFrame': 'Up to 5 years', 'description': 'Characterized using descriptive statistics. If differences are noted between pre- and post-treatment protein expression, pairwise comparisons will be made using paired t-test or an equivalent nonparametric test. The normality assumption will be assessed on the log-transformed data prior to paired t-test evaluation.'}, {'measure': 'Change in Stem Cell Percentage', 'timeFrame': 'Baseline to post-treatment with bortezomib', 'description': 'Will use descriptive statistics to assess mean +/- standard deviation for stem cell percentage before and after bortezomib treatment. If there appears to be a difference in responders vs. non-responders, stem cell percentage differences between responders and non-responders will be compared using a paired t-test or equivalent nonparametric test.'}, {'measure': 'Plasma Concentration-time Profiles', 'timeFrame': 'Up to day 8 of block 2', 'description': 'Will be analyzed using descriptive statistics and will be graphically displayed by age group and stratum. PK data will be analyzed using methods such as nonlinear mixed effects modeling to estimate bortezomib clearance and volume of distribution (and the associated 95% confidence intervals) in each age group (2-11 years and 12-16 years of age).'}, {'measure': 'Pharmacokinetics (PK) of Bortezomib in Patients Receiving Multi-agent Combination Therapy.', 'timeFrame': 'Day 8 of blocks 1 and 2', 'description': 'This outcome measure cannot be reported due to the data used for analysis was not collected.'}], 'primaryOutcomes': [{'measure': 'Second Complete Remission Rate at the End of Block 1 Reinduction Chemotherapy', 'timeFrame': 'The outcome is measured the end of Block 1 (Day 36 of Block 1) of re-induction therapy.', 'description': 'The percentage of eligible and evaluable patients who have achieved complete response at the end Block 1 of re-induction therapy.'}, {'measure': 'Event Free Survival', 'timeFrame': '4 months after enrollment', 'description': 'Percentage of patients who were event free at 4 months'}, {'measure': 'Toxic Death Rate', 'timeFrame': '4 months', 'description': 'The proportion of toxic death rate among all eligible patients.'}, {'measure': 'Severe Adverse Events (SAE) Rate.', 'timeFrame': '4 months', 'description': 'The proportion of SAE rate among all eligible patients'}], 'secondaryOutcomes': [{'measure': 'Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 1', 'timeFrame': 'End of Block 1 (Day 36 of Block 1) of re-induction therapy', 'description': 'Percentage of eligible and evaluable patients with MRD \\< 0.01% among those who had successful MRD determination at the end of Block 1.'}, {'measure': 'Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 2', 'timeFrame': 'End of Block 2 (Day 36 of Block 2) of re-induction therapy', 'description': 'Percentage of eligible and evaluable patients with MRD \\< 0.01% among those who had successful MRD determination at the end of Block 2.'}, {'measure': 'Rate of Minimal Residual Disease (MRD) < 0.01% at End Block 3', 'timeFrame': 'End of Block 3 (Day 36 of Block 3) of re-induction therapy', 'description': 'Percentage of eligible and evaluable patients with MRD \\< 0.01% among those who had successful MRD determination at the end of Block 3.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['B-cell Adult Acute Lymphoblastic Leukemia', 'B-cell Childhood Acute Lymphoblastic Leukemia', 'Recurrent Adult Acute Lymphoblastic Leukemia', 'Recurrent Adult Lymphoblastic Lymphoma', 'Recurrent Childhood Acute Lymphoblastic Leukemia', 'Recurrent Childhood Lymphoblastic Lymphoma', 'T-cell Adult Acute Lymphoblastic Leukemia', 'T-cell Childhood Acute Lymphoblastic Leukemia']}, 'referencesModule': {'references': [{'pmid': '30957229', 'type': 'DERIVED', 'citation': "Horton TM, Whitlock JA, Lu X, O'Brien MM, Borowitz MJ, Devidas M, Raetz EA, Brown PA, Carroll WL, Hunger SP. Bortezomib reinduction chemotherapy in high-risk ALL in first relapse: a report from the Children's Oncology Group. Br J Haematol. 2019 Jul;186(2):274-285. doi: 10.1111/bjh.15919. Epub 2019 Apr 7."}, {'pmid': '28419486', 'type': 'DERIVED', 'citation': 'Hanley MJ, Mould DR, Taylor TJ, Gupta N, Suryanarayan K, Neuwirth R, Esseltine DL, Horton TM, Aplenc R, Alonzo TA, Lu X, Milton A, Venkatakrishnan K. Population Pharmacokinetic Analysis of Bortezomib in Pediatric Leukemia Patients: Model-Based Support for Body Surface Area-Based Dosing Over the 2- to 16-Year Age Range. J Clin Pharmacol. 2017 Sep;57(9):1183-1193. doi: 10.1002/jcph.906. Epub 2017 Apr 18.'}]}, 'descriptionModule': {'briefSummary': 'This pilot, phase II trial studies the side effects of giving bortezomib together with combination chemotherapy and to see how well it works in treating young patients with relapsed acute lymphoblastic leukemia or lymphoblastic lymphoma. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with combination chemotherapy may kill more cancer cells.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To estimate the toxicity, second complete response (CR2) rate at the end of Block 1 therapy, and 4-month event-free survival (EFS) for pediatric and young adult patients with relapsed acute lymphoblastic leukemia (ALL) treated with bortezomib in combination with intensive re-induction chemotherapy.\n\nII. To evaluate bortezomib pharmacokinetics (PK) in patients receiving the combination regimen.\n\nSECONDARY OBJECTIVES:\n\nI. To assess minimal residual disease (MRD) in bone marrow following completion of each therapy block.\n\nII. To assess the feasibility of measuring leukemia initiating cells (LIC) in patient samples before and after chemotherapy.\n\nIII. To discover biologic pathways associated with response and drug resistance using gene and protein expression profiles at baseline and following initial exposure to chemotherapy.\n\nIV. To determine if bortezomib inhibits lymphoblast nuclear factor (NF)-kappa (k)-B activity in leukemia patients.\n\nOUTLINE:\n\nREINDUCTION BLOCK 1: Patients receive cytarabine intrathecally (IT) on day 1; vincristine sulfate IV over 1 minute on days 1, 8, 15, and 22; doxorubicin hydrochloride IV over 15 minutes on day 1; prednisone orally (PO) twice daily (BID) on days 1-28; bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11; and pegaspargase intramuscularly (IM) or IV over 1-2 hours on days 2, 8, 15, and 22. Patients with central nervous system (CNS)-negative disease (CNS1 or CNS2) also receive methotrexate IT on days 15 and 29; patients with CNS-positive disease (CNS3) receive triple intrathecal therapy (TIT) comprising methotrexate, hydrocortisone, and cytarabine IT on days 8, 15, 22, and 29. After completion of reinduction block 1, patients with ALL and M2 or M3 bone marrow proceed directly to reinduction block 2. Patients with ALL and M1 bone marrow or lymphoblastic lymphoma proceed to reinduction block 2 after blood counts recover. Patients with persistent cerebral spinal fluid (CSF) blasts after 6 doses of TIT or patients with progressive lymphoblastic lymphoma are removed from the study.\n\nREINDUCTION BLOCK 2: Patients receive etoposide phosphate IV over 1-2 hours on days 1-5; cyclophosphamide IV over 15-30 minutes on days 1-5; bortezomib IV over 3-5 seconds on days 1, 4, and 8; filgrastim (G-CSF) subcutaneously (SC) or IV daily beginning on day 6 and continuing until blood counts recover\\*; high-dose methotrexate IV over 24 hours on day 22; and leucovorin calcium PO or IV every 6 hours on days 23 and 24. Patients with CNS-negative disease also receive methotrexate IT on days 1 and 22; patients with CNS-positive disease receive TIT on days 1 and 22. After completion of reinduction block 2, patients proceed to reinduction block 3 immediately or when blood counts recover. Patients with disease progression are removed from the study.\n\nNOTE: \\*Patients do not receive G-CSF on day 8.\n\nREINDUCTION BLOCK 3: Patients receive cytarabine IV over 3 hours BID on days 1, 2, 8, and 9; L-asparaginase IM on days 2 and 9; and G-CSF SC or IV daily beginning on day 10 and continuing until blood counts recover.\n\nAfter completion of study treatment, patients are followed every 6 months for 3 years and then annually for 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '31 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis\n\n * Pre-B ALL in first early (\\< 36 months from diagnosis) isolated bone marrow (BM) or combined BM/extramedullary relapse; or\n * T-cell ALL in first isolated BM or combined relapse; or\n * T-LL in first relapse\n* Patients with leukemia must have had histologic verification of the malignancy at relapse, including immunophenotyping to confirm diagnosis\n* Patients with lymphoblastic lymphoma must have measurable disease documented by clinical, radiographic, or histologic criteria; patients must have relapsed or become refractory to conventional therapy\n* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2; use Karnofsky for patients \\> 16 years of age and Lansky for patients =\\< 16 years of age\n* Patients who relapse while receiving standard ALL maintenance chemotherapy will not be required to have a waiting period before entry onto this study\n* Patients who relapse on therapy other than standard ALL maintenance therapy must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study\n* At least 14 days since the completion of cytotoxic therapy with the exception of hydroxyurea, which is permitted up to 24 hours prior to the start of protocol therapy\n* At least 7 days since the completion of therapy with a biologic agent or donor lymphocyte infusions (DLI); for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur\n* No evidence of active graft-vs-host disease (GVHD) and \\>= 4 months must have elapsed; must not be receiving GVHD prophylaxis\n* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \\>= 70 mL/min/1.73 m\\^2 or a serum creatinine based on age/gender as follows:\n\n * 1 month to \\< 6 months (0.4 male, 0.4 female)\n * 6 months to \\< 1 year (0.5 male, 0.5 female)\n * 1 to \\< 2 years (0.6 male, 0.6 female)\n * 2 to \\< 6 years (0.8 male, 0.8 female)\n * 6 to \\< 10 years (1 male, 1 female)\n * 10 to \\< 13 years (1.2 male, 1.2 female)\n * 13 to \\< 16 years (1.5 male, 1.4 female)\n * \\>= 16 years (1.7 male, 1.4 female)\n* Total bilirubin =\\< 1.5 x upper limit of normal (ULN) for age\n* Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) \\< 3 x ULN for age, unless elevation due to leukemia infiltration\n* Shortening fraction of \\>= 27% by echocardiogram, or\n* Ejection fraction of \\>= 50% by gated radionuclide study\n* No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \\>= 94% at sea level (\\> 90% if at high altitude)\n* No evidence of acute pulmonary infiltrates on chest radiograph\n* Patients with seizure disorder may be enrolled if on allowed anticonvulsants and well controlled; benzodiazepines and gabapentin are acceptable\n* Central nervous system (CNS) toxicity =\\< grade 2\n* Peripheral nervous system (PNS) toxicity \\< grade 3\n* All patients and/or their parents or legal guardians must sign a written informed consent\n* All institutional, FDA, and National Cancer Institute (NCI) requirements for human studies must be met\n\nExclusion Criteria:\n\n* Patients with Philadelphia chromosome positive ALL are not eligible unless refractory to at least one tyrosine kinase inhibitor (TKI) therapy; patients that are unable to tolerate TKI therapy due to toxicity are eligible\n* Patients with mature B-cell ALL, ie, leukemia with B-cell (soluble immunoglobulin \\[sIg\\] positive and kappa or lambda restricted positivity) ALL, with French-American-British (FAB) L3 morphology and/or a myc translocation, are not eligible\n* Extramedullary disease status: patients with isolated CNS disease or isolated testicular disease are not eligible\n* Patients with known optic nerve and/or retinal involvement are not eligible; patients presenting with visual disturbances should have an ophthalmological exam and, if indicated, an magnetic resonance imaging (MRI) to determine optic nerve or retinal involvement\n* Patients with concomitant genetic syndrome: patients with Down syndrome, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome are not eligible\n* Cumulative prior anthracycline exposure must not exceed 400 mg/m\\^2\n* Patients taking anticonvulsants known to activate the cytochrome p450 system, in particular anticonvulsants such as phenytoin, carbamazepine, and phenobarbital, are not eligible; benzodiazepines and gabapentin are acceptable\n* Patients who have previously received bortezomib or other proteasome inhibitors are not eligible\n* Patients who have a known allergy to doxorubicin, cytarabine, both etoposide and etopophos, boron, mannitol or bortezomib are not eligible\n* Patients who cannot receive any asparaginase products (E. Coli, PEG-asparaginase, or Erwinia asparaginase) on this study (eg, due to prior severe pancreatitis, stroke or other toxicity) are not eligible; patients who initially receive asparaginase, but must discontinue due to toxicity, remain eligible; patients with clinically significant prior allergies to pegaspargase are eligible if Erwinia L-asparaginase can be substituted\n* Patients who are pregnant or breast-feeding are not eligible for this study; negative pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective birth control method\n* Patients must not have received any prior re-induction attempts and must not have received treatment for prior extramedullary relapse; patients with primary induction failure are not eligible'}, 'identificationModule': {'nctId': 'NCT00873093', 'briefTitle': 'Bortezomib and Combination Chemotherapy in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase II Pilot Trial of Bortezomib (PS-341, Velcade) in Combination With Intensive Re-Induction Therapy for Children With Relapsed Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)', 'orgStudyIdInfo': {'id': 'NCI-2011-01908'}, 'secondaryIdInfos': [{'id': 'NCI-2011-01908', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'AALL07P1', 'type': 'OTHER', 'domain': "Children's Oncology Group"}, {'id': 'AALL07P1', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'U10CA180886', 'link': 'https://reporter.nih.gov/quickSearch/U10CA180886', 'type': 'NIH'}, {'id': 'U10CA098543', 'link': 'https://reporter.nih.gov/quickSearch/U10CA098543', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pre-B ALL Relapse<18 mths from diagnosis (chemo) age<=21 yrs', 'description': 'Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine.', 'interventionNames': ['Drug: L-asparaginase', 'Drug: doxorubicin hydrochloride', 'Drug: therapeutic hydrocortisone', 'Drug: vincristine sulfate', 'Drug: cytarabine', 'Drug: prednisone', 'Drug: bortezomib', 'Drug: pegaspargase', 'Drug: methotrexate', 'Drug: etoposide phosphate', 'Drug: cyclophosphamide', 'Biological: filgrastim', 'Drug: leucovorin calcium', 'Other: laboratory biomarker analysis', 'Drug: High Dose MTX']}, {'type': 'EXPERIMENTAL', 'label': 'Pre-B ALL Relapse 18-36 mths from diagnosis (chemo) age<=21 yr', 'description': 'Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine.', 'interventionNames': ['Drug: L-asparaginase', 'Drug: doxorubicin hydrochloride', 'Drug: therapeutic hydrocortisone', 'Drug: vincristine sulfate', 'Drug: cytarabine', 'Drug: prednisone', 'Drug: bortezomib', 'Drug: pegaspargase', 'Drug: methotrexate', 'Drug: etoposide phosphate', 'Drug: cyclophosphamide', 'Biological: filgrastim', 'Drug: leucovorin calcium', 'Other: laboratory biomarker analysis', 'Drug: High Dose MTX']}, {'type': 'EXPERIMENTAL', 'label': 'Pre-B ALL Relapse<36 mths from diagnosis (chemo) age>21 yrs', 'description': 'Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine.', 'interventionNames': ['Drug: L-asparaginase', 'Drug: doxorubicin hydrochloride', 'Drug: therapeutic hydrocortisone', 'Drug: vincristine sulfate', 'Drug: cytarabine', 'Drug: prednisone', 'Drug: bortezomib', 'Drug: pegaspargase', 'Drug: methotrexate', 'Drug: etoposide phosphate', 'Drug: cyclophosphamide', 'Biological: filgrastim', 'Drug: leucovorin calcium', 'Other: laboratory biomarker analysis', 'Drug: High Dose MTX']}, {'type': 'EXPERIMENTAL', 'label': 'T-cell ALL (Chemotherapy)', 'description': 'Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine.', 'interventionNames': ['Drug: L-asparaginase', 'Drug: doxorubicin hydrochloride', 'Drug: therapeutic hydrocortisone', 'Drug: vincristine sulfate', 'Drug: cytarabine', 'Drug: prednisone', 'Drug: bortezomib', 'Drug: pegaspargase', 'Drug: methotrexate', 'Drug: etoposide phosphate', 'Drug: cyclophosphamide', 'Biological: filgrastim', 'Drug: leucovorin calcium', 'Other: laboratory biomarker analysis', 'Drug: High Dose MTX']}, {'type': 'EXPERIMENTAL', 'label': 'T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)', 'description': 'Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine.', 'interventionNames': ['Drug: L-asparaginase', 'Drug: doxorubicin hydrochloride', 'Drug: therapeutic hydrocortisone', 'Drug: vincristine sulfate', 'Drug: cytarabine', 'Drug: prednisone', 'Drug: bortezomib', 'Drug: pegaspargase', 'Drug: methotrexate', 'Drug: etoposide phosphate', 'Drug: cyclophosphamide', 'Biological: filgrastim', 'Drug: leucovorin calcium', 'Other: laboratory biomarker analysis', 'Drug: High Dose MTX']}], 'interventions': [{'name': 'L-asparaginase', 'type': 'DRUG', 'otherNames': ['ASNase', 'Colaspase', 'Crasnitin', 'Elspar', 'L-ASP'], 'description': 'Given IM 6000 IU/m2/dose Days 2 and 9', 'armGroupLabels': ['Pre-B ALL Relapse 18-36 mths from diagnosis (chemo) age<=21 yr', 'Pre-B ALL Relapse<18 mths from diagnosis (chemo) age<=21 yrs', 'Pre-B ALL Relapse<36 mths from diagnosis (chemo) age>21 yrs', 'T-cell ALL (Chemotherapy)', 'T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)']}, {'name': 'doxorubicin hydrochloride', 'type': 'DRUG', 'otherNames': ['ADM', 'ADR', 'Adria'], 'description': 'Given IV 60 mg/m2/dose on Day 1', 'armGroupLabels': ['Pre-B ALL Relapse 18-36 mths from diagnosis (chemo) age<=21 yr', 'Pre-B ALL Relapse<18 mths from diagnosis (chemo) age<=21 yrs', 'Pre-B ALL Relapse<36 mths from diagnosis (chemo) age>21 yrs', 'T-cell ALL (Chemotherapy)', 'T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)']}, {'name': 'therapeutic hydrocortisone', 'type': 'DRUG', 'otherNames': ['Aeroseb-HC', 'Barseb HC', 'Cetacort', 'Cort-Dome', 'Cortef'], 'description': 'Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 and 29 Block 2: Days 1 and 22', 'armGroupLabels': ['Pre-B ALL Relapse 18-36 mths from diagnosis (chemo) age<=21 yr', 'Pre-B ALL Relapse<18 mths from diagnosis (chemo) age<=21 yrs', 'Pre-B ALL Relapse<36 mths from diagnosis (chemo) age>21 yrs', 'T-cell ALL (Chemotherapy)', 'T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)']}, {'name': 'vincristine sulfate', 'type': 'DRUG', 'otherNames': ['liposomal vincristine', 'Marqibo', 'vincristine liposomal', 'vincristine sulfate liposome injection'], 'description': 'Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22', 'armGroupLabels': ['Pre-B ALL Relapse 18-36 mths from diagnosis (chemo) age<=21 yr', 'Pre-B ALL Relapse<18 mths from diagnosis (chemo) age<=21 yrs', 'Pre-B ALL Relapse<36 mths from diagnosis (chemo) age>21 yrs', 'T-cell ALL (Chemotherapy)', 'T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)']}, {'name': 'cytarabine', 'type': 'DRUG', 'otherNames': ['ARA-C', 'arabinofuranosylcytosine', 'arabinosylcytosine', 'Cytosar-U', 'cytosine arabinoside'], 'description': 'Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 and 9', 'armGroupLabels': ['Pre-B ALL Relapse 18-36 mths from diagnosis (chemo) age<=21 yr', 'Pre-B ALL Relapse<18 mths from diagnosis (chemo) age<=21 yrs', 'Pre-B ALL Relapse<36 mths from diagnosis (chemo) age>21 yrs', 'T-cell ALL (Chemotherapy)', 'T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)']}, {'name': 'prednisone', 'type': 'DRUG', 'otherNames': ['DeCortin', 'Deltra'], 'description': 'Given PO or IV 40 mg/m2/day on Days 1-28', 'armGroupLabels': ['Pre-B ALL Relapse 18-36 mths from diagnosis (chemo) age<=21 yr', 'Pre-B ALL Relapse<18 mths from diagnosis (chemo) age<=21 yrs', 'Pre-B ALL Relapse<36 mths from diagnosis (chemo) age>21 yrs', 'T-cell ALL (Chemotherapy)', 'T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)']}, {'name': 'bortezomib', 'type': 'DRUG', 'otherNames': ['LDP 341', 'MLN341', 'VELCADE'], 'description': 'Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 and 11 Block 2: Days 1, 4 and 8', 'armGroupLabels': ['Pre-B ALL Relapse 18-36 mths from diagnosis (chemo) age<=21 yr', 'Pre-B ALL Relapse<18 mths from diagnosis (chemo) age<=21 yrs', 'Pre-B ALL Relapse<36 mths from diagnosis (chemo) age>21 yrs', 'T-cell ALL (Chemotherapy)', 'T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)']}, {'name': 'pegaspargase', 'type': 'DRUG', 'otherNames': ['L-asparaginase with polyethylene glycol', 'Oncaspar', 'PEG-ASP', 'PEG-L-asparaginase'], 'description': 'Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 and 22', 'armGroupLabels': ['Pre-B ALL Relapse 18-36 mths from diagnosis (chemo) age<=21 yr', 'Pre-B ALL Relapse<18 mths from diagnosis (chemo) age<=21 yrs', 'Pre-B ALL Relapse<36 mths from diagnosis (chemo) age>21 yrs', 'T-cell ALL (Chemotherapy)', 'T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)']}, {'name': 'methotrexate', 'type': 'DRUG', 'otherNames': ['amethopterin', 'Folex', 'methylaminopterin', 'Mexate', 'MTX'], 'description': 'Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 and 29 Block 2: Days 1 and 22', 'armGroupLabels': ['Pre-B ALL Relapse 18-36 mths from diagnosis (chemo) age<=21 yr', 'Pre-B ALL Relapse<18 mths from diagnosis (chemo) age<=21 yrs', 'Pre-B ALL Relapse<36 mths from diagnosis (chemo) age>21 yrs', 'T-cell ALL (Chemotherapy)', 'T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)']}, {'name': 'etoposide phosphate', 'type': 'DRUG', 'otherNames': ['ETOP', 'Etopophos'], 'description': 'Given IV 100 mg/m2/dose on Days 1-5', 'armGroupLabels': ['Pre-B ALL Relapse 18-36 mths from diagnosis (chemo) age<=21 yr', 'Pre-B ALL Relapse<18 mths from diagnosis (chemo) age<=21 yrs', 'Pre-B ALL Relapse<36 mths from diagnosis (chemo) age>21 yrs', 'T-cell ALL (Chemotherapy)', 'T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)']}, {'name': 'cyclophosphamide', 'type': 'DRUG', 'otherNames': ['CPM', 'CTX', 'Cytoxan', 'Endoxan', 'Endoxana'], 'description': 'Given IV 440 mg/m2/dose on Days 1-5', 'armGroupLabels': ['Pre-B ALL Relapse 18-36 mths from diagnosis (chemo) age<=21 yr', 'Pre-B ALL Relapse<18 mths from diagnosis (chemo) age<=21 yrs', 'Pre-B ALL Relapse<36 mths from diagnosis (chemo) age>21 yrs', 'T-cell ALL (Chemotherapy)', 'T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)']}, {'name': 'filgrastim', 'type': 'BIOLOGICAL', 'otherNames': ['G-CSF', 'Neupogen'], 'description': 'Given IV or SC 5 micrograms/kg/dose Only on Day 6', 'armGroupLabels': ['Pre-B ALL Relapse 18-36 mths from diagnosis (chemo) age<=21 yr', 'Pre-B ALL Relapse<18 mths from diagnosis (chemo) age<=21 yrs', 'Pre-B ALL Relapse<36 mths from diagnosis (chemo) age>21 yrs', 'T-cell ALL (Chemotherapy)', 'T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)']}, {'name': 'leucovorin calcium', 'type': 'DRUG', 'otherNames': ['CF', 'CFR', 'LV'], 'description': 'Given PO or IV 15mg/m2/dose q6h x 3 doses', 'armGroupLabels': ['Pre-B ALL Relapse 18-36 mths from diagnosis (chemo) age<=21 yr', 'Pre-B ALL Relapse<18 mths from diagnosis (chemo) age<=21 yrs', 'Pre-B ALL Relapse<36 mths from diagnosis (chemo) age>21 yrs', 'T-cell ALL (Chemotherapy)', 'T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Pre-B ALL Relapse 18-36 mths from diagnosis (chemo) age<=21 yr', 'Pre-B ALL Relapse<18 mths from diagnosis (chemo) age<=21 yrs', 'Pre-B ALL Relapse<36 mths from diagnosis (chemo) age>21 yrs', 'T-cell ALL (Chemotherapy)', 'T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)']}, {'name': 'High Dose MTX', 'type': 'DRUG', 'otherNames': ['methotrexate', 'amethopterin', 'Folex', 'methylaminopterin', 'Mexate'], 'description': 'IV 5000 mg/m2/dose Block 2: Day 22', 'armGroupLabels': ['Pre-B ALL Relapse 18-36 mths from diagnosis (chemo) age<=21 yr', 'Pre-B ALL Relapse<18 mths from diagnosis (chemo) age<=21 yrs', 'Pre-B ALL Relapse<36 mths from diagnosis (chemo) age>21 yrs', 'T-cell ALL (Chemotherapy)', 'T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': "Children's Hospital of Alabama", 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix Childrens Hospital', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72202-3591', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Hospital", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90242', 'city': 'Downey', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Permanente Medical Group', 'geoPoint': {'lat': 33.94001, 'lon': -118.13257}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Medical Center', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': "Miller Children's Hospital", 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '93636-8762', 'city': 'Madera', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Central California", 'geoPoint': {'lat': 36.96134, 'lon': -120.06072}}, {'zip': '94609-1809', 'city': 'Oakland', 'state': 'California', 'country': 'United 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