Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT01027702
Status:
TERMINATED
Last Update Posted:
2022-04-22
First Post:
2009-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Donor Lymphocyte Infusion After Alternative Donor Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gilmanandy@prahs.com', 'phone': '704-615-2744', 'title': 'Dr. Andrew Gilman', 'organization': 'PRA Health Sciences'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From the time of donor lymphocyte infusion (DLI) up to one year after transplant.', 'description': 'Infections that met the definition of a Serious Adverse Event are reported as the type of infection, when the cause of infection was known.', 'eventGroups': [{'id': 'EG000', 'title': 'Infusion of Donor Lymphocytes', 'description': 'Patients will receive an infusion of donor lymphocyte after T-cell depleted transplant.\n\nInfusion of donor lymphocytes: A donor lymphocyte infusion will be given to provide T cells. There will be a dose escalation: 3 x 10\\^4, 4 x 10\\^4, 5 x 10\\^4, 6 X 10\\^4, 8 x 10\\^4, and 10 X10\\^4 cells/kg body weight. At least three patients will be assessed at each dose to determine safety before dose is increased.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 27, 'seriousNumAtRisk': 38, 'deathsNumAffected': 12, 'seriousNumAffected': 32}], 'otherEvents': [{'term': 'Neutropenia', 'notes': 'grade 4', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Leukopenia', 'notes': 'grade 4', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypoxia', 'notes': 'grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Rash', 'notes': 'grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Thrombotic microangiopathy', 'notes': 'grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Thrombotic microangiopathy', 'notes': 'grade 4', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'ALT elevated', 'notes': 'grade 4', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hemorrage, GU- urinary NOS', 'notes': 'Hemorrhagic cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypertension', 'notes': 'grade 4', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypokalemia', 'notes': 'grade 4', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain', 'notes': 'grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Renal/ Genitorurinary NOS', 'notes': 'grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Seizures', 'notes': 'grade 3', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Lymphopenia', 'notes': 'grade 4', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypoxia', 'notes': 'grade 4', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'HHV-6 reactivation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Graft vs Host disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 5}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'EBV-related lymphoproliferative disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'CMV reactivation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection w/ unknown absolute neutrophil count (ANC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Thrombotic Microangiopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'ALT/ AST elevated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection- eye NOS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pulmonary/ Upper Respiratory- other', 'notes': 'Blood tinged sputum following fungal pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'BK virus/ hemorrhagic cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Infection- select', 'notes': 'viral upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Immune Recovery Following Transplantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'MMRD: 3 x 10^4/kg DLI + MTX to Day +24', 'description': 'Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 3 x 10\\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Day +1, +3, +10, +17, and +24'}, {'id': 'OG001', 'title': 'MMRD: 3 x 10^4/kg DLI + MTX to Day +52', 'description': 'Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 3 x 10\\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52'}, {'id': 'OG002', 'title': 'MMRD: 4 x 10^4/kg DLI + MTX to Day +52', 'description': 'Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 4 x 10\\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52'}, {'id': 'OG003', 'title': 'MMRD: 4 x 10^4/kg DLI + MTX to Day +80', 'description': 'Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 4 x 10\\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45, +52, +59, +66, +73, and +80'}, {'id': 'OG004', 'title': 'MMRD: 5 x 10^4/kg DLI + MTX to Day +80', 'description': 'Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 5 x 10\\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45, +52, +59, +66, +73, and +80'}, {'id': 'OG005', 'title': 'MUD: 3 x 10^4/kg DLI + MTX to Day +24', 'description': 'Matched Unrelated Donor: Donor Lymphocyte Infusion (DLI) 3 x 10\\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Day +1, +3, +10, +17, and +24'}, {'id': 'OG006', 'title': 'MUD: 3 x 10^4/kg DLI + MTX to Day +52', 'description': 'Matched Unrelated Donor: Donor Lymphocyte Infusion (DLI) 3 x 10\\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006'], 'groupDescription': 'This was a dose-escalation study to determine a target DLI dose at which the:\n\n1. Probability of CD4+ cells \\> 100/µL by Day +120 is at least 66% and\n2. Probability of grade II and III GVHD is at most 33%, probability of grade III GVHD is at most 17%, and no grade IV GVHD occurs Patients were assigned in cohorts of 3.', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The study design consisted of two phases, a dose-escalation phase and a dose-confirmation phase. In the dose-escalation phase, patients were assigned in cohorts of 3. The dose escalation plan was:\n\n* If a grade IV acute GVHD event was observed at any dose, no more patients were assigned to this or higher dose levels unless the methotrexate dosing was modified.\n* If none of the initial three patients at a dose level experienced grade II/III GVHD and \\< 2/3 had a CD4+ count \\> 100 at Day +120, the next three patients were assigned to the next higher dose level.\n* If 1 out of 3 patients had grade III GVHD or 1 - 2 out of 3 patients had grade II GVHD and/or \\> 2/3 have a CD4+ count \\> 100 at Day +120, the dose was repeated for the next 3 patients.\n\nThe dose of 5 x 10\\^4 CD3+ cells/kg was determined to be the optimal dose.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '120 days after transplant', 'description': 'Immune recovery was measured by CD4+ cells \\> 100/μL by Day 120 following transplantation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who received subsequent therapy, such as therapeutic DLI (eg. for treatment of viral infection or relapse), chemotherapy, or a PBSC infusion were considered not evaluable as this could interfere with response assessments.'}, {'type': 'PRIMARY', 'title': 'Incidence and Severity of GVHD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'MMRD: 3 x 10^4/kg DLI + MTX to Day +24', 'description': 'Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 3 x 10\\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Day +1, +3, +10, +17, and +24'}, {'id': 'OG001', 'title': 'MMRD: 3 x 10^4/kg DLI + MTX to Day +52', 'description': 'Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 3 x 10\\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52'}, {'id': 'OG002', 'title': 'MMRD: 4 x 10^4/kg DLI + MTX to Day +52', 'description': 'Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 4 x 10\\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52'}, {'id': 'OG003', 'title': 'MMRD: 4 x 10^4/kg DLI + MTX to Day +80', 'description': 'Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 4 x 10\\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45, +52, +59, +66, +73, and +80'}, {'id': 'OG004', 'title': 'MMRD: 5 x 10^4/kg DLI + MTX to Day +80', 'description': 'Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 5 x 10\\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45, +52, +59, +66, +73, and +80'}, {'id': 'OG005', 'title': 'MUD: 3 x 10^4/kg DLI + MTX to Day +24', 'description': 'Matched Unrelated Donor: Donor Lymphocyte Infusion (DLI) 3 x 10\\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Day +1, +3, +10, +17, and +24'}, {'id': 'OG006', 'title': 'MUD: 3 x 10^4/kg DLI + MTX to Day +52', 'description': 'Matched Unrelated Donor: Donor Lymphocyte Infusion (DLI) 3 x 10\\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52'}], 'classes': [{'categories': [{'title': 'No GVHD/ Grade I GVHD', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}, {'title': 'Grade II GVHD', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}, {'title': 'Grade III/IV GVHD', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006'], 'groupDescription': 'This was a dose-escalation study to determine a target DLI dose at which the:\n\n1. Probability of CD4+ cells \\> 100/µL by Day +120 is at least 66% and\n2. Probability of grade II and III GVHD is at most 33%, probability of grade III GVHD is at most 17%, and no grade IV GVHD occurs Patients were assigned in cohorts of 3.', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The study design consisted of two phases, a dose-escalation phase and a dose-confirmation phase. In the dose-escalation phase, patients were assigned in cohorts of 3. The dose escalation plan was:\n\nIf a grade IV acute GVHD event was observed at any dose, no more patients were assigned to this or higher dose levels unless the methotrexate dosing was modified.\n\nIf none of the initial three patients at a dose level experienced grade II/III GVHD and \\< 2/3 had a CD4+ count \\> 100 at Day +120, the next three patients were assigned to the next higher dose level.\n\nIf 1 out of 3 patients had grade III GVHD or 1 - 2 out of 3 patients had grade II GVHD and/or \\> 2/3 have a CD4+ count \\> 100 at Day +120, the dose was repeated for the next 3 patients.\n\nThe dose of 5 x 10\\^4 CD3+ cells/kg was determined to be the optimal dose.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '180 days after transplant', 'description': 'Patients were evaluated for acute GVHD due to prophylactic DLI between the day of prophylactic DLI infusion and Day +180 after transplant. GVHD was graded using standard criteria.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients that had not had grade II-IV acute GVHD following prophylactic DLI but received therapeutic DLI (eg. for treatment of viral infection or relapse), chemotherapy, or a PBSC infusion prior to Day +180 were considered not evaluable because these therapies may cause or prevent GVHD and affect the determination of this endpoint.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Infection and EBV-related Post-transplant Lymphoproliferative Disease (PTLD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Infusion of Donor Lymphocytes', 'description': 'Patients will receive an infusion of donor lymphocyte after T-cell depleted transplant.\n\nInfusion of donor lymphocytes: A donor lymphocyte infusion will be given to provide T cells. There will be a dose escalation: 3 x 10\\^4, 4 x 10\\^4, 5 x 10\\^4, 6 X 10\\^4, 8 x 10\\^4, and 10 X10\\^4 cells/kg body weight. At least three patients will be assessed at each dose to determine safety before dose is increased.'}], 'classes': [{'title': 'HHV-6 reactivation, no disease', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Viral upper respiratory infections', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Adenovirus reactivation, no disease', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Clostridium difficile colitis', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Sinusitis', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'CMV reactivation, no disease', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Galactomannan positive', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'BK virus, no disease', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'BK virus, hemorrhagic cystitis', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'EBV-related lymphoproliferative disease', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Bacteremia, gram negative', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Herpes simplex virus', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Bacteremia, gram positive', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Acute otitis media', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Candidiasis (non-invasive)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Pneumonia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Infection with normal ANC - grade 3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Adenovirus disease', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'EBV reactivation, no disease', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Varicella', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Nocardia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Pneumonia- fungal', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Methicillin-resistant staphylococcus aureus (MRSA)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Norovirus', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Parvovirus B19 (low level)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Rotavirus', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Sapovirus', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Possible respiratory fungal infection (rhizomucor)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'Subjects were actively monitored for adenovirus, cytomegalovirus (CMV), human herpes virus 6 (HHV6), and Epstein-Barr virus (EBV) as part of standard post-transplant care. All infections were collected from date of DLI until 1 year after transplant.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who relapsed and received subsequent chemotherapy were no longer followed for infections as these therapies increase the risk of infections.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MMRD: 3 x 10^4/kg DLI + MTX to Day +24', 'description': 'Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 3 x 10\\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Day +1, +3, +10, +17, and +24'}, {'id': 'FG001', 'title': 'MMRD: 3 x 10^4/kg DLI + MTX to Day +52', 'description': 'Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 3 x 10\\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52'}, {'id': 'FG002', 'title': 'MMRD: 4 x 10^4/kg DLI + MTX to Day +52', 'description': 'Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 4 x 10\\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52'}, {'id': 'FG003', 'title': 'MMRD: 4 x 10^4/kg DLI + MTX to Day +80', 'description': 'Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 4 x 10\\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45, +52, +59, +66, +73, and +80'}, {'id': 'FG004', 'title': 'MMRD: 5 x 10^4/kg DLI + MTX to Day +80', 'description': 'Mismatched Related Donor: Donor Lymphocyte Infusion (DLI) 5 x 10\\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45, +52, +59, +66, +73, and +80'}, {'id': 'FG005', 'title': 'MUD: 3 x 10^4/kg DLI + MTX to Day +24', 'description': 'Matched Unrelated Donor: Donor Lymphocyte Infusion (DLI) 3 x 10\\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Day +1, +3, +10, +17, and +24'}, {'id': 'FG006', 'title': 'MUD: 3 x 10^4/kg DLI + MTX to Day +52', 'description': 'Matched Unrelated Donor: Donor Lymphocyte Infusion (DLI) 3 x 10\\^4 cells/kg followed by methotrexate (MTX) 10 mg/m2 on Days +1, +3, +10, +17, and +24, 7.5 mg/m2 on Days +31 and +38, 5 mg/m2 on days +45 and +52'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Received subsequent therapy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Patients who received a CD34+ selected peripheral blood stem cell (PBSC) transplant on the companion study, LCH BMT 09-01, at Levine Children's Hospital between December 2009 and June 2016.", 'preAssignmentDetails': 'Subjects were enrolled to two cohorts based on donor type, Mismatched Related Donor (MMRD) and Matched Unrelated Donor (MUD).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Infusion of Donor Lymphocytes', 'description': 'Patients will receive an infusion of donor lymphocyte after T-cell depleted transplant.\n\nInfusion of donor lymphocytes: A donor lymphocyte infusion will be given to provide T cells. There will be a dose escalation: 3 x 10\\^4, 4 x 10\\^4, 5 x 10\\^4, 6 X 10\\^4, 8 x 10\\^4, and 10 X10\\^4 cells/kg body weight. At least three patients will be assessed at each dose to determine safety before dose is increased.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '< 1 year', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': '1-2 years', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': '2-4 years', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': '4-6 years', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': '6-8 years', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': '8-10 years', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': '10-12 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': '12-14 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': '14-16 years', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': '16-18 years', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': '> 18 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-11-14', 'size': 997390, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2017-07-31T11:51', 'hasProtocol': True}, {'date': '2014-11-14', 'size': 260008, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2017-07-31T11:52', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'whyStopped': 'Sponsor/ PI leaving institution, no plans to continue this research at this time', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-20', 'studyFirstSubmitDate': '2009-12-07', 'resultsFirstSubmitDate': '2017-09-09', 'studyFirstSubmitQcDate': '2009-12-08', 'lastUpdatePostDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-10-08', 'studyFirstPostDateStruct': {'date': '2009-12-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Immune Recovery Following Transplantation', 'timeFrame': '120 days after transplant', 'description': 'Immune recovery was measured by CD4+ cells \\> 100/μL by Day 120 following transplantation'}, {'measure': 'Incidence and Severity of GVHD', 'timeFrame': '180 days after transplant', 'description': 'Patients were evaluated for acute GVHD due to prophylactic DLI between the day of prophylactic DLI infusion and Day +180 after transplant. GVHD was graded using standard criteria.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Infection and EBV-related Post-transplant Lymphoproliferative Disease (PTLD)', 'timeFrame': '1 year', 'description': 'Subjects were actively monitored for adenovirus, cytomegalovirus (CMV), human herpes virus 6 (HHV6), and Epstein-Barr virus (EBV) as part of standard post-transplant care. All infections were collected from date of DLI until 1 year after transplant.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Donor Lymphocyte Infusion', 'Immune Recovery', 'T cell depleted transplant', 'Mismatched related donor transplants', 'Unrelated donor transplants'], 'conditions': ['Immunodeficiency']}, 'referencesModule': {'references': [{'pmid': '29047161', 'type': 'DERIVED', 'citation': 'Gilman AL, Leung W, Cowan MJ, Cannon M, Epstein S, Barnhart C, Shah K, Hyland M, Fukes T, Ivanova A. Donor lymphocyte infusion and methotrexate for immune recovery after T-cell depleted haploidentical transplantation. Am J Hematol. 2018 Feb;93(2):169-178. doi: 10.1002/ajh.24949. Epub 2017 Nov 17.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the ability of a donor lymphocyte infusion (DLI) given with methotrexate to hasten immune recovery without causing severe graft-versus-host disease (GVHD) in recipients who have had a T-cell depleted transplant.', 'detailedDescription': 'Studies have shown that giving donor T cells after a mismatched T cell-depleted stem cell transplant can speed up recovery of T cells in the patient. This approach can cause severe graft versus host disease (GVHD). The purpose of this study is to determine whether giving a donor lymphocyte infusion (DLI) with methotrexate can accelerate immune recovery in recipients of T cell-depleted stem cell transplants. Thirty days after a T-cell depleted transplant, patients will be given a DLI. They will be monitored for immune recovery as measured by CD4 count and for GVHD toxicity.\n\nPatients will be separated into six cohorts based on dose of DLI received: 3 x 10\\^4, 4 x 10\\^4, 5 x 10\\^4, 6 X 10\\^4, 8 x 10\\^4, and 10 X10\\^4 cells/ kg of body weight. A minimum of 3 patients will be tested at each dose starting with the lowest dose. Dose escalation will continue until the dose associated with CD4 count \\>100 at Day +120 after transplant without significant GVHD is determined. All patients will receive thirteen doses of methotrexate after the DLI to prevent GVHD. Patients will be followed for 2 years for outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have been treated on the LCH BMT 09-01 protocol\n* Signed informed consent by patient or legal guardian\n\nExclusion Criteria:\n\n* Active GVHD at the time when DLI are due\n* History of acute GVHD \\> grade I prior to DLI\n* Disease due to viral infection (eg. CMV) when DLI are due (asymptomatic viral replication or viral shedding is not a contraindication)\n* Uncontrolled bacterial or fungal infection\n* O2 saturation by pulse oximetry \\< 95%\n* Bilirubin \\> 3mg/dL or ALT \\> 5 x upper limit of normal\n* Creatinine \\> 3x baseline (at transplant)\n* ANC (WBC x % neutrophils + bands) \\< 500/ul\n* Significant effusions (eg. pleural or pericardial) or ascites\n* EBV-related PTLD\n* Persistent or increasing mixed chimerism requiring therapeutic DLI as defined on the LCH BMT 09-01 protocol'}, 'identificationModule': {'nctId': 'NCT01027702', 'briefTitle': 'Donor Lymphocyte Infusion After Alternative Donor Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Phase I/II Study of Donor Lymphocyte Infusion With Methotrexate GVHD Prophylaxis to Hasten Immune Reconstitution After CD34+ Cell-Selected Transplant', 'orgStudyIdInfo': {'id': 'LCH BMT 09-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Infusion of donor lymphocytes', 'description': 'Patients will receive an infusion of donor lymphocyte after T-cell depleted transplant.', 'interventionNames': ['Biological: Infusion of donor lymphocytes']}], 'interventions': [{'name': 'Infusion of donor lymphocytes', 'type': 'BIOLOGICAL', 'description': 'A donor lymphocyte infusion will be given to provide T cells. There will be a dose escalation: 3 x 10\\^4, 4 x 10\\^4, 5 x 10\\^4, 6 X 10\\^4, 8 x 10\\^4, and 10 X10\\^4 cells/kg body weight. At least three patients will be assessed at each dose to determine safety before dose is increased.', 'armGroupLabels': ['Infusion of donor lymphocytes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': "Levine Children's Hospital, Carolinas Medical Center", 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], 'overallOfficials': [{'name': 'Andrew Gilman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Department of Pediatrics, Levine Children's Hospital, Carolinas Healthcare System"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}