Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-29 @ 2:24 AM
Study NCT ID:
NCT00412360
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
2006-12-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Single vs Double Umbilical Cord Blood Transplants in Children With High Risk Leukemia and Myelodysplasia (BMT CTN 0501)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'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': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014916', 'term': 'Whole-Body Irradiation'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'C024352', 'term': 'fludarabine'}, {'id': 'C042382', 'term': 'fludarabine phosphate'}, {'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amendizabal@EMMES.com', 'phone': '301-251-1161', 'title': 'Adam Mendizabal', 'organization': 'The EMMES Corporation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '2 years post-transplant', 'description': 'Serious Adverse Events (AE) are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event. Only unexpected grades 3-5 adverse events were required to be reported through the AE system per protocol.', 'eventGroups': [{'id': 'EG000', 'title': 'Single UCB Transplant', 'description': 'Single Umbilical Cord Blood Unit Transplantation', 'otherNumAtRisk': 112, 'otherNumAffected': 0, 'seriousNumAtRisk': 112, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Double UCB Transplant', 'description': 'Double Umbilical Cord Blood Unit Transplantation', 'otherNumAtRisk': 108, 'otherNumAffected': 0, 'seriousNumAtRisk': 108, 'seriousNumAffected': 14}], 'seriousEvents': [{'term': 'Hemolytic anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Congestive heart failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pneumonia', 'notes': 'Respiratory failure from Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Acute intracranial Hemorrage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Seizure/aspiration Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pulmonary Hemorrage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Aspiration Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 112, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Single UCB Transplant', 'description': 'Single Umbilical Cord Blood Unit Transplantation'}, {'id': 'OG001', 'title': 'Double UCB Transplant', 'description': 'Double Umbilical Cord Blood Unit Transplantation'}], 'classes': [{'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000', 'lowerLimit': '63', 'upperLimit': '80'}, {'value': '65', 'groupId': 'OG001', 'lowerLimit': '56', 'upperLimit': '74'}]}]}], 'analyses': [{'pValue': '0.17', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Testing was performed at a significance level of 0.05', 'groupDescription': 'The null hypothesis is that there is no difference in overall survival at one year post-randomization between participants receiving single- and double-unit cord blood transplant. The targeted sample size of 110 participants per treatment group was sufficient to maintain a type I error rate of 5% and provide more than 86% power to detect an increase in overall survival from 57% among participants receiving a single unit graft to 77% for those receiving a double-unit graft.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '1 year post-randomization', 'description': 'Overall survival is defined as survival of death from any cause.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Disease-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Single UCB Transplant', 'description': 'Single Umbilical Cord Blood Unit Transplantation'}, {'id': 'OG001', 'title': 'Double UCB Transplant', 'description': 'Double Umbilical Cord Blood Unit Transplantation'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000', 'lowerLimit': '60', 'upperLimit': '77'}, {'value': '64', 'groupId': 'OG001', 'lowerLimit': '54', 'upperLimit': '72'}]}]}], 'analyses': [{'pValue': '0.11', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Testing was performed at a significance level of 0.05', 'groupDescription': 'The null hypothesis is that there is no difference in disease-free survival at one year post-randomization between participants receiving single- and double-unit cord blood transplant.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '1 year post-randomization', 'description': 'Disease-free survival is defined as survival without relapse of the primary disease.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Neutrophil and Platelet Engraftment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Single UCB Transplant', 'description': 'Single Umbilical Cord Blood Unit Transplantation'}, {'id': 'OG001', 'title': 'Double UCB Transplant', 'description': 'Double Umbilical Cord Blood Unit Transplantation'}], 'classes': [{'title': 'Neutrophil Engraftment at Day 42', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000', 'lowerLimit': '83', 'upperLimit': '95'}, {'value': '88', 'groupId': 'OG001', 'lowerLimit': '82', 'upperLimit': '94'}]}]}, {'title': 'Platelet Engraftment at Day 100', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000', 'lowerLimit': '68', 'upperLimit': '85'}, {'value': '65', 'groupId': 'OG001', 'lowerLimit': '56', 'upperLimit': '74'}]}]}], 'analyses': [{'pValue': '0.29', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Testing was performed at a significance level of 0.05', 'groupDescription': 'The null hypothesis is that there is no difference in the cumulative incidence of neutrophil engraftment between participants receiving single- and double-unit cord blood transplant.', 'statisticalMethod': "Gray's test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Testing was performed at a significance level of 0.05', 'groupDescription': 'The null hypothesis is that there is no difference in the cumulative incidence of platelet engraftment between participants receiving single- and double-unit cord blood transplant.', 'statisticalMethod': "Gray's test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Days 42 and 100', 'description': 'Neutrophil engraftment is defined as achieving an absolute neutrophil count greater than 500x10\\^6/liter for three consecutive measurements on different days. The first of the three days will be designated the day of neutrophil engraftment. Platelet engraftment is defined as achieving platelet counts greater than 50,000/microliter for consecutive measurements over 7 days without requiring platelet transfusions. The first of the 7 days will be designated the day of platelet engraftment. Subjects must not have had platelet transfusions during the preceding 7 days.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Transplanted participants'}, {'type': 'SECONDARY', 'title': 'Time to Neutrophil and Platelet Engraftment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Single UCB Transplant', 'description': 'Single Umbilical Cord Blood Unit Transplantation'}, {'id': 'OG001', 'title': 'Double UCB Transplant', 'description': 'Double Umbilical Cord Blood Unit Transplantation'}], 'classes': [{'title': 'Neutrophil Engraftment', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '62'}, {'value': '23', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '133'}]}]}, {'title': 'Platelet Engraftment', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000', 'lowerLimit': '28', 'upperLimit': '295'}, {'value': '84', 'groupId': 'OG001', 'lowerLimit': '22', 'upperLimit': '716'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '2 years post-transplant', 'description': 'Platelet engraftment is defined as achieving platelet counts greater than 50,000/microliter for consecutive measurements over 7 days without requiring platelet transfusions. The first of the 7 days will be designated the day of platelet engraftment. Subjects must not have had platelet transfusions during the preceding 7 days.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Transplanted participants'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Acute Graft-versus-host Disease (GVHD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Single UCB Transplant', 'description': 'Single Umbilical Cord Blood Unit Transplantation'}, {'id': 'OG001', 'title': 'Double UCB Transplant', 'description': 'Double Umbilical Cord Blood Unit Transplantation'}], 'classes': [{'title': 'Acute GVHD Grade II-IV', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000', 'lowerLimit': '48', 'upperLimit': '67'}, {'value': '56', 'groupId': 'OG001', 'lowerLimit': '47', 'upperLimit': '65'}]}]}, {'title': 'Acute GVHD Grade III-IV', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '20'}, {'value': '23', 'groupId': 'OG001', 'lowerLimit': '15', 'upperLimit': '31'}]}]}], 'analyses': [{'pValue': '0.78', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Testing was performed at a significance level of 0.05', 'groupDescription': 'The null hypothesis is that there is no difference in the cumulative incidence of Grade II-IV acute GVHD between participants receiving single- and double-unit cord blood transplant.', 'statisticalMethod': "Gray's test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Testing was performed at a significance level of 0.05', 'groupDescription': 'The null hypothesis is that there is no difference in the cumulative incidence of Grade III-IV acute GVHD between participants receiving single- and double-unit cord blood transplant.', 'statisticalMethod': "Gray's test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 100 post-randomization', 'description': 'Acute GVHD is graded according to the scoring system proposed by Przepiorka et al.1995:\n\nSkin stage:\n\n0: No rash\n\n1. Rash \\<25% of body surface area\n2. Rash on 25-50% of body surface area\n3. Rash on \\> 50% of body surface area\n4. Generalized erythroderma with bullous formation\n\nLiver stage (based on bilirubin level)\\*:\n\n0: \\<2 mg/dL\n\n1. 2-3 mg/dL\n2. 3.01-6 mg/dL\n3. 6.01-15.0 mg/dL\n4. \\>15 mg/dL\n\nGI stage\\*:\n\n0: No diarrhea or diarrhea \\<500 mL/day\n\n1. Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD\n2. Diarrhea 1000-1499 mL/day\n3. Diarrhea \\>1500 mL/day\n4. Severe abdominal pain with or without ileus \\* If multiple etiologies are listed for liver or GI, the organ system is downstaged by 1.\n\nGVHD grade:\n\n0: All organ stages 0 or GVHD not listed as an etiology I: Skin stage 1-2 and liver and GI stage 0 II: Skin stage 3 or liver or GI stage 1 III: Liver stage 2-3 or GI stage 2-4 IV: Skin or liver stage 4', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Transplanted participants'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Chronic GVHD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Single UCB Transplant', 'description': 'Single Umbilical Cord Blood Unit Transplantation'}, {'id': 'OG001', 'title': 'Double UCB Transplant', 'description': 'Double Umbilical Cord Blood Unit Transplantation'}], 'classes': [{'title': 'Chronic GVHD', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '39'}, {'value': '32', 'groupId': 'OG001', 'lowerLimit': '23', 'upperLimit': '40'}]}]}, {'title': 'Extensive Chronic GVHD', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '14'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '22'}]}]}], 'analyses': [{'pValue': '0.51', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Testing was performed at a significance level of 0.05', 'groupDescription': 'The null hypothesis is that there is no difference in the cumulative incidence of chronic GVHD between participants receiving single- and double-unit cord blood transplant.', 'statisticalMethod': "Gray's test", 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Testing was performed at a significance level of 0.05', 'groupDescription': 'The null hypothesis is that there is no difference in the cumulative incidence of extensive chronic GVHD between participants receiving single- and double-unit cord blood transplant.', 'statisticalMethod': "Gray's test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '1 year post-randomization', 'description': 'Incidences of chronic GVHD will be graded per Shulman et al. 1980. This reference categorizes chronic GVHD as either limited or extensive. For this outcome, participants developing either type are considered to have a chronic GVHD event.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Transplanted participants'}, {'type': 'SECONDARY', 'title': 'Number of Infections Per Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Single UCB Transplant', 'description': 'Single Umbilical Cord Blood Unit Transplantation'}, {'id': 'OG001', 'title': 'Double UCB Transplant', 'description': 'Double Umbilical Cord Blood Unit Transplantation'}], 'classes': [{'categories': [{'title': '0', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': '1', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': '2', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': '3', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': '4', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': '5', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'title': '6-10', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'title': 'More than 10', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 years post-randomization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Transplanted participants'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Single UCB Transplant', 'description': 'Single Umbilical Cord Blood Unit Transplantation'}, {'id': 'OG001', 'title': 'Double UCB Transplant', 'description': 'Double Umbilical Cord Blood Unit Transplantation'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '18'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '7', 'upperLimit': '21'}]}]}], 'analyses': [{'pValue': '0.12', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Testing was performed at a significance level of 0.05', 'groupDescription': 'The null hypothesis is that there is no difference in the cumulative incidence of relapse between participants receiving single- and double-unit cord blood transplant.', 'statisticalMethod': "Gray's test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '1 year post-randomization', 'description': 'Relapse is defined by either morphological or cytogenetic evidence of AML, ALL, CML, or MDS consistent with pre-transplant features. Testing for recurrent malignancy in the blood, marrow or other sites will be used to assess relapse after transplantation.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Transplanted participants'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment-related Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Single UCB Transplant', 'description': 'Single Umbilical Cord Blood Unit Transplantation'}, {'id': 'OG001', 'title': 'Double UCB Transplant', 'description': 'Double Umbilical Cord Blood Unit Transplantation'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '26'}, {'value': '22', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '30'}]}]}], 'analyses': [{'pValue': '0.43', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Testing was performed at a significance level of 0.05', 'groupDescription': 'The null hypothesis is that there is no difference in the cumulative incidence of treatment-related mortality between participants receiving single- and double-unit cord blood transplant.', 'statisticalMethod': "Gray's test", 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '1 year post-randomization', 'description': 'Treatment related mortality is defined as death without relapse of the primary disease.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Transplanted participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Engraftment Syndrome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Single UCB Transplant', 'description': 'Single Umbilical Cord Blood Unit Transplantation'}, {'id': 'OG001', 'title': 'Double UCB Transplant', 'description': 'Double Umbilical Cord Blood Unit Transplantation'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 100 post-transplant', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Transplanted participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Single UCB Transplant', 'description': 'Single Cord Blood Unit Transplantation: Unrelated donor, single cord blood unit'}, {'id': 'FG001', 'title': 'Double UCB Transplant', 'description': 'Double Cord Blood Unit Transplantation: Unrelated donor, double cord blood unit'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '113'}, {'groupId': 'FG001', 'numSubjects': '111'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '112'}, {'groupId': 'FG001', 'numSubjects': '108'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Not Transplanted', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Single UCB Transplant', 'description': 'Single Umbilical Cord Blood Unit Transplantation'}, {'id': 'BG001', 'title': 'Double UCB Transplant', 'description': 'Double Umbilical Cord Blood Unit Transplantation'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10.4', 'spread': '5.1', 'groupId': 'BG000'}, {'value': '10.4', 'spread': '5.1', 'groupId': 'BG001'}, {'value': '10.4', 'spread': '5.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Primary Disease', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Acute Myelogenous Leukemia (AML)', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}, {'title': 'Acute Lymphoblastic Leukemia (ALL)', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}, {'title': 'Acute Biphenotypic Leukemia', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Acute Undifferentiated Leukemia', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Myelodysplastic Syndrome (MDS)', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Chronic Myelogenous Leukemia (CML)', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'AML Disease Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}], 'categories': [{'title': 'First Complete Remission (CR)', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Second or Later CR', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'First Relapse', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Morphologic CR before Complete-Blood-Count Recover', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Secondary or Therapy-related', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Participants with AML'}, {'title': 'ALL Disease Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}], 'categories': [{'title': 'First Complete Remission (CR)', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Second CR', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'Subsequent CR', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'Morphologic CR before Complete-Blood-Count Recover', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Participants with ALL'}, {'title': 'Acute Biphenotypic Leukemia Disease Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}], 'categories': [{'title': 'First Complete Remission (CR)', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Second CR', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Participants with Acute Biphenotypic Leukemia'}, {'title': 'MDS Disease Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Refractory Anemia', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Refractory Cytopenia with Multilineage Dysplasia', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Refractory Anemia with Excess Blasts 1 (RAEB1)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Refractory Anemia with Excess Blasts 2 (RAEB2)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unclassified', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'RAEB1: Blast percentage of 5-10%; RAEB2: Blast percentage of 11-20%', 'unitOfMeasure': 'Participants', 'populationDescription': 'Participants with MDS'}, {'title': 'Karnofsky Performance Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}], 'categories': [{'title': '100%', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}, {'title': '90%', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}, {'title': '80%', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': '70%', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Assesses patient self-perceived global quality of life and functioning (excellent, very good, good, fair, poor), where 100 equals perfect quality of life.', 'unitOfMeasure': 'Participants'}, {'title': 'Recipient CMV Status', 'classes': [{'title': 'Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}]}, {'title': 'Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}]}, {'title': 'Inconclusive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight at Infusion', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '39.6', 'spread': '20.2', 'groupId': 'BG000'}, {'value': '38.7', 'spread': '19.2', 'groupId': 'BG001'}, {'value': '39.15', 'spread': '19.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Recipient to First Cord Blood Unit HLA Match', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}], 'categories': [{'title': '3/6', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': '4/6', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}, {'title': '5/6', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}, {'title': '6/6', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Transplanted participants'}, {'title': 'Recipient to Second Cord Blood Unit HLA Match', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}], 'categories': [{'title': '3/6', 'measurements': [{'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': '4/6', 'measurements': [{'value': '43', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': '5/6', 'measurements': [{'value': '43', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': '6/6', 'measurements': [{'value': '21', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Double UCB transplant participants'}, {'title': 'Recipient to First Cord Blood Unit ABO Match', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Major Mismatch', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'Minor Mismatch', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'Bidirectional Mismatch', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'No Mismatch', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Blood type matching between recipient and cord blood unit', 'unitOfMeasure': 'Participants', 'populationDescription': 'Transplanted participants'}, {'title': 'Recipient to Second Cord Blood Unit ABO Match', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Major mismatch', 'measurements': [{'value': '31', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Minor mismatch', 'measurements': [{'value': '29', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Bidirectional mismatch', 'measurements': [{'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'No mismatch', 'measurements': [{'value': '38', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Blood type matching between recipient and cord blood unit', 'unitOfMeasure': 'Participants', 'populationDescription': 'Double UCB transplant participants'}], 'populationDescription': 'Analysis based on intent-to-treat.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2010-03-18', 'size': 1062817, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2021-10-12T15:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 224}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-13', 'studyFirstSubmitDate': '2006-12-14', 'resultsFirstSubmitDate': '2015-08-28', 'studyFirstSubmitQcDate': '2006-12-14', 'lastUpdatePostDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-11-17', 'studyFirstPostDateStruct': {'date': '2006-12-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Overall Survival', 'timeFrame': '1 year post-randomization', 'description': 'Overall survival is defined as survival of death from any cause.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Disease-free Survival', 'timeFrame': '1 year post-randomization', 'description': 'Disease-free survival is defined as survival without relapse of the primary disease.'}, {'measure': 'Percentage of Participants With Neutrophil and Platelet Engraftment', 'timeFrame': 'Days 42 and 100', 'description': 'Neutrophil engraftment is defined as achieving an absolute neutrophil count greater than 500x10\\^6/liter for three consecutive measurements on different days. The first of the three days will be designated the day of neutrophil engraftment. Platelet engraftment is defined as achieving platelet counts greater than 50,000/microliter for consecutive measurements over 7 days without requiring platelet transfusions. The first of the 7 days will be designated the day of platelet engraftment. Subjects must not have had platelet transfusions during the preceding 7 days.'}, {'measure': 'Time to Neutrophil and Platelet Engraftment', 'timeFrame': '2 years post-transplant', 'description': 'Platelet engraftment is defined as achieving platelet counts greater than 50,000/microliter for consecutive measurements over 7 days without requiring platelet transfusions. The first of the 7 days will be designated the day of platelet engraftment. Subjects must not have had platelet transfusions during the preceding 7 days.'}, {'measure': 'Percentage of Participants With Acute Graft-versus-host Disease (GVHD)', 'timeFrame': 'Day 100 post-randomization', 'description': 'Acute GVHD is graded according to the scoring system proposed by Przepiorka et al.1995:\n\nSkin stage:\n\n0: No rash\n\n1. Rash \\<25% of body surface area\n2. Rash on 25-50% of body surface area\n3. Rash on \\> 50% of body surface area\n4. Generalized erythroderma with bullous formation\n\nLiver stage (based on bilirubin level)\\*:\n\n0: \\<2 mg/dL\n\n1. 2-3 mg/dL\n2. 3.01-6 mg/dL\n3. 6.01-15.0 mg/dL\n4. \\>15 mg/dL\n\nGI stage\\*:\n\n0: No diarrhea or diarrhea \\<500 mL/day\n\n1. Diarrhea 500-999 mL/day or persistent nausea with histologic evidence of GVHD\n2. Diarrhea 1000-1499 mL/day\n3. Diarrhea \\>1500 mL/day\n4. Severe abdominal pain with or without ileus \\* If multiple etiologies are listed for liver or GI, the organ system is downstaged by 1.\n\nGVHD grade:\n\n0: All organ stages 0 or GVHD not listed as an etiology I: Skin stage 1-2 and liver and GI stage 0 II: Skin stage 3 or liver or GI stage 1 III: Liver stage 2-3 or GI stage 2-4 IV: Skin or liver stage 4'}, {'measure': 'Percentage of Participants With Chronic GVHD', 'timeFrame': '1 year post-randomization', 'description': 'Incidences of chronic GVHD will be graded per Shulman et al. 1980. This reference categorizes chronic GVHD as either limited or extensive. For this outcome, participants developing either type are considered to have a chronic GVHD event.'}, {'measure': 'Number of Infections Per Participant', 'timeFrame': '2 years post-randomization'}, {'measure': 'Percentage of Participants With Relapse', 'timeFrame': '1 year post-randomization', 'description': 'Relapse is defined by either morphological or cytogenetic evidence of AML, ALL, CML, or MDS consistent with pre-transplant features. Testing for recurrent malignancy in the blood, marrow or other sites will be used to assess relapse after transplantation.'}, {'measure': 'Percentage of Participants With Treatment-related Mortality', 'timeFrame': '1 year post-randomization', 'description': 'Treatment related mortality is defined as death without relapse of the primary disease.'}, {'measure': 'Number of Participants With Engraftment Syndrome', 'timeFrame': 'Day 100 post-transplant'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Double cord blood'], 'conditions': ['Acute Myelogenous Leukemia', 'Acute Lymphocytic Leukemia', 'Chronic Myelogenous Leukemia', 'Myelodysplastic Syndrome', 'Natural Killer Cell Lymphoblastic Leukemia/Lymphoma']}, 'referencesModule': {'references': [{'pmid': '6996481', 'type': 'BACKGROUND', 'citation': 'Shulman HM, Sullivan KM, Weiden PL, McDonald GB, Striker GE, Sale GE, Hackman R, Tsoi MS, Storb R, Thomas ED. Chronic graft-versus-host syndrome in man. A long-term clinicopathologic study of 20 Seattle patients. Am J Med. 1980 Aug;69(2):204-17. doi: 10.1016/0002-9343(80)90380-0.'}, {'pmid': '25354103', 'type': 'RESULT', 'citation': 'Wagner JE Jr, Eapen M, Carter S, Wang Y, Schultz KR, Wall DA, Bunin N, Delaney C, Haut P, Margolis D, Peres E, Verneris MR, Walters M, Horowitz MM, Kurtzberg J; Blood and Marrow Transplant Clinical Trials Network. One-unit versus two-unit cord-blood transplantation for hematologic cancers. N Engl J Med. 2014 Oct 30;371(18):1685-94. doi: 10.1056/NEJMoa1405584.'}], 'seeAlsoLinks': [{'url': 'https://www.nmdp.org', 'label': 'National Marrow Donor Program'}]}, 'descriptionModule': {'briefSummary': 'This study is a Phase III, randomized, open-label, multi-center, prospective study of single umbilical cord blood (UCB) transplantation versus double UCB transplantation in pediatric patients with hematologic malignancies.', 'detailedDescription': 'BACKGROUND:\n\nIn nearly every large single center or registry analysis of outcomes after UCB transplantation, cell dose is identified as an important factor influencing the incidence and rate of hematopoietic recovery, risk of transplant-related mortality, and probability of survival. Pilot data suggest that infusion of two partially human leukocyte antigen (HLA)-matched UCB units, which always augments the graft cell dose, is safe and may improve neutrophil recovery and survival. To determine whether the infusion of two UCB units enhances survival, a multi-center, open-label, randomized trial is proposed. As adequate single UCB units can be identified for more than 80% of pediatric recipients (in contrast to less than 30% for adults), this study will be open only to pediatric patients. The population will be restricted to patients with high-risk hematologic malignancy, the most common indication of UCB transplantation in children.\n\nDESIGN NARRATIVE:\n\nParticipants will include patients 1 to 21 years of age with a diagnosis of hematological malignancy and with two partially HLA-matched UCB units. Units must be HLA-matched at 3 of 6 HLA-A and B (intermediate resolution molecular typing) and DRB1 (high resolution molecular typing) with each other and 4 of 6 with the recipient. Two appropriately HLA-matched units must be available such that one unit delivers a pre-cryopreserved, nucleated cell dose of at least 2.5 x 10\\^7 per kilogram and the second unit delivers at least 1.5 x 10\\^7 per kilogram.\n\nPatients will be randomized no more than 14 days prior to initiation of conditioning. UCB units will be shipped prior to initiation of conditioning.\n\nThe preparative regimen will consist of the following:\n\n* Fludarabine: 25 mg/m2/day IV on Days -10, -9, and -8.\n* Total Body Irradiation (TBI): 165 cGy twice daily on Days -7, -6, -5, and -4.\n* Cyclophosphamide: 60 mg/kg/day x 2 on Days -3 and -2.\n* Day 0 will be the day of the UCB transplant. The Graft-vs-Host-Disease (GVHD) prophylaxis regimen will be mycophenolate mofetil (MMF) 15 mg/kg IV BID on Day -3 to Day + 45 and cyclosporine A (CSA) to maintain level 200-400 ng/mL beginning on Day -3.\n\nPatients will be followed for at least 24 months post-transplant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Two partially HLA-matched UCB units. Units must be HLA-matched minimally at 4 of 6 HLA-A and B (at intermediate resolution by molecular typing) and DRB1 (at high resolution by molecular typing) loci with the patient, and the units must be HLA-matched at 3 of 6 HLA- A, B, DRB1 loci with each other (using same resolution of molecular typing as indicated above). Two appropriately HLA-matched units must be available such that one unit delivers a pre-cryopreserved nucleated cell dose of at least 2.5 x 10\\^7 per kilogram and the second unit at least 1.5 x 10\\^7 per kilogram.\n* Acute myelogenous leukemia (AML) at the following stages:\n\n 1. High risk first complete remission (CR1), defined as the following:\n\n * Having preceding myelodysplasia (MDS)\n * High risk cytogenetics (high risk cytogenetics: del (5q) -5, -7, abn (3q), t (6;9) complex karyotype \\[at least 5 abnormalities\\],)the presence of a high FLT3 ITD-AR (\\> 0.4)\n * Requiring more than 1 cycle of chemotherapy to obtain complete remission (CR);\n * FAB M6\n 2. Second or greater CR\n 3. First relapse with less than 25% blasts in bone marrow\n 4. Morphologic complete remission with incomplete blood count recovery\n* Therapy-related AML for which prior malignancy has been in remission for at least 12 months\n* Acute lymphocytic leukemia (ALL) at the following stages:\n\n 1. High risk first remission, defined as one of the following conditions:\n\n * Philadelphia chromosome-positive adult lymphoblastic leukemia (Ph+ ALL)\n * Mixed lineage leukemia (MLL) rearrangement with slow early response (defined as having M2 \\[5-25% blasts\\] or M3 \\[more than 25% blasts on bone marrow examination on Day 14 of induction therapy\\])\n * Hypodiploidy (less than 44 chromosomes or DNA index less than 0.81)\n * End of induction M3 bone marrow\n * End of induction M2 with M2-3 at Day 42\n * Evidence of minimal residual disease (MRD). If a patient's only high risk criterion is MRD, approval by a protocol chair or protocol officer is required for enrollment. For COG centers, this will only be for MRD greater than 1 percent by flow MRD at the end of extended induction.\n 2. High risk second remission, defined as one of the following conditions:\n\n * Philadelphia chromosome-positive adult lymphoblastic leukemia (Ph+ ALL)\n * Bone marrow relapse less than 36 months from induction\n * T-lineage relapse at any time\n * Very early isolated central nervous system (CNS) relapse (6 months from diagnosis)\n * Slow reinduction (M2-3 at Day 28) after relapse at any time\n * Evidence of minimal residual disease (MRD). If a patient's only high risk criterion is MRD, approval by a protocol chair or protocol officer is required for enrollment. For COG centers, this will only be for MRD greater than 1 percent by flow MRD at the end of extended induction.\n 3. Any third or subsequent CR\n* NK cell lymphoblastic leukemia in any CR\n* Biphenotypic or undifferentiated leukemia in any CR or if in first relapse must have less than 25% blasts in bone marrow (BM)\n* Myelodysplastic syndrome (MDS) at any stage\n* Chronic myelogenous leukemia (CML) in chronic or accelerated phase\n* All patients with evidence of CNS leukemia must be treated and be in CNS CR to be eligible for study.\n* Patients 16 years old or older must have a Karnofsky score of at least 70% and patients younger than 16 years old must have a Lansky score of at least 70%.\n* Patients with adequate physical function as measured by:\n\n 1. Cardiac: Left ventricular ejection fraction greater than 40% or shortening fraction greater than 26%\n 2. Hepatic: Bilirubin no more than 2.5 mg/dL; alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) no more than 5 times the upper limit of normal (ULN)\n 3. Renal: Serum creatinine within normal range for age, or if serum creatinine is outside normal range for age, then renal function (creatinine clearance or GFR) greater than 70 mL/min/1.73 m\\^2\n 4. Pulmonary: Diffusing capacity of the lung for carbon monoxide (DLCO), forced expiratory volume in one second (FEV1), or forced vital capacity (FVC) greater than 50% of predicted value (corrected for hemoglobin); if unable to perform pulmonary function tests, then O2 saturation greater than 92% of room air\n\nExclusion Criteria:\n\n* Pregnant (β-positive human chorionic gonadotropin \\[HCG\\]) or breastfeeding\n* Evidence of HIV infection or HIV positive serology\n* Current uncontrolled bacterial, viral, or fungal infection (currently taking medication and progression of clinical symptoms)\n* Autologous transplant less than 12 months prior to enrollment\n* Prior autologous transplant for the disease for which the UCB transplant will be performed\n* Prior allogeneic hematopoietic stem cell transplant\n* Active malignancy other than the one for which the UCB transplant is being performed within 12 months of enrollment\n* Inability to receive TBI\n* Requirement of supplemental oxygen\n* HLA-matched related donor able to donate"}, 'identificationModule': {'nctId': 'NCT00412360', 'briefTitle': 'Single vs Double Umbilical Cord Blood Transplants in Children With High Risk Leukemia and Myelodysplasia (BMT CTN 0501)', 'nctIdAliases': ['NCT00429598'], 'organization': {'class': 'OTHER', 'fullName': 'Medical College of Wisconsin'}, 'officialTitle': 'Multi-center, Open Label, Randomized Trial Comparing Single Versus Double Umbilical Cord Blood (UCB) Transplantation in Pediatric Patients With High Risk Leukemia and Myelodysplasia (BMT CTN #0501)', 'orgStudyIdInfo': {'id': 'BMTCTN0501'}, 'secondaryIdInfos': [{'id': '2U01HL069294', 'link': 'https://reporter.nih.gov/quickSearch/2U01HL069294', 'type': 'NIH'}, {'id': '5U24CA076518', 'link': 'https://reporter.nih.gov/quickSearch/5U24CA076518', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Cord Blood Transplant', 'description': 'Unrelated donor, single umbilical cord blood unit transplant; conditioning regimen: Total Body Irradiation/cyclophosphamide/fludarabine; GVHD prophylaxis: Cyclosporine A/Mycophenolate Mofetil', 'interventionNames': ['Biological: Single Umbilical Cord Blood Unit Transplant', 'Radiation: Total Body Irradiation', 'Drug: Cyclophosphamide', 'Drug: Fludarabine', 'Drug: Cyclosporine A', 'Drug: Mycophenolate Mofetil']}, {'type': 'EXPERIMENTAL', 'label': 'Double Cord Blood Transplant', 'description': 'Unrelated donor, double umbilical cord blood unit transplant; Conditioning regimen: Total Body Irradiation/cyclophosphamide/fludarabine; GVHD prophylaxis: Cyclosporine A/Mycophenolate Mofetil', 'interventionNames': ['Biological: Double Umbilical Cord Blood Unit Transplant', 'Radiation: Total Body Irradiation', 'Drug: Cyclophosphamide', 'Drug: Fludarabine', 'Drug: Cyclosporine A', 'Drug: Mycophenolate Mofetil']}], 'interventions': [{'name': 'Single Umbilical Cord Blood Unit Transplant', 'type': 'BIOLOGICAL', 'description': 'Unrelated donor, single umbilical cord blood unit; conditioning regimen: TBI/cyclophosphamide/fludarabine; GVHD prophylaxis: cyclosporine/MMF', 'armGroupLabels': ['Single Cord Blood Transplant']}, {'name': 'Double Umbilical Cord Blood Unit Transplant', 'type': 'BIOLOGICAL', 'description': 'Unrelated donor, double umbilical cord blood unit; Conditioning regimen: TBI/cyclophosphamide/fludarabine; GVHD prophylaxis: cyclosporine/MMF', 'armGroupLabels': ['Double Cord Blood Transplant']}, {'name': 'Total Body Irradiation', 'type': 'RADIATION', 'otherNames': ['TBI'], 'description': 'The TBI will be delivered from either a linear accelerator or cobalt source at a dose rate of between 4 and 26 cGy/minute using energies of between 1 and 25 MV.', 'armGroupLabels': ['Double Cord Blood Transplant', 'Single Cord Blood Transplant']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['Cytoxan®'], 'description': 'Cyclophosphamide 60 mg/kg/day will be administered as a 2 hour intravenous infusion with a high volume fluid flush on Days -3 and -2.', 'armGroupLabels': ['Double Cord Blood Transplant', 'Single Cord Blood Transplant']}, {'name': 'Fludarabine', 'type': 'DRUG', 'otherNames': ['Fludara'], 'description': 'Fludarabine 25 mg/m2/day will be administered over 30-60 minutes intravenous infusion on Days -10 through -8. Fludarabine will not be dose adjusted for body weight.', 'armGroupLabels': ['Double Cord Blood Transplant', 'Single Cord Blood Transplant']}, {'name': 'Cyclosporine A', 'type': 'DRUG', 'otherNames': ['CSA'], 'description': 'CSA will be administered beginning on Day -3 and doses will be adjusted to maintain a level of 200-400 ng/mL by TDX method (or 100-250 ng/mL by Tandem MS or equivalent level for other CSA testing methods). CSA can be administered per institutional practice.', 'armGroupLabels': ['Double Cord Blood Transplant', 'Single Cord Blood Transplant']}, {'name': 'Mycophenolate Mofetil', 'type': 'DRUG', 'otherNames': ['MMF, Cellcept®'], 'description': 'MMF will be given at a dose of 1 gram IV q 8 hours if \\> 50 kg or 15 mg/kg IV q 8 hours if \\< 50 kg beginning the morning of Day -3.', 'armGroupLabels': ['Double Cord Blood Transplant', 'Single Cord Blood Transplant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "Phoenix Children's Hospital", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope National Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Childrens Hospital at Oakland', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'UCSD/Rady Childrens Hospital', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco (Peds)', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': "The Children's Hospital of Denver", 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Medical Center", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida College of Medicine (Shands)', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Nemours Childrens Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33710', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': "All Children's Hospital", 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '30322-1062', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Medical Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': "University of Louisville/Kosiar Children's Hospital", 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70118', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': "Children's of New Orleans", 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "DFCI/Children's Hospital of Boston", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Medical Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': "Karmanos Cancer Institute/Children's Hospital of Michigan", 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospital and Clinics", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '10595', 'city': 'Valhalla', 'state': 'New York', 'country': 'United States', 'facility': 'New York Medical College', 'geoPoint': {'lat': 41.07482, 'lon': -73.77513}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '43205-2696', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health Sciences University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '37232-7610', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': "Children's Medical Center of Dallas", 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Cook Childrens Medical Center', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Transplant Institute', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Utah BMT/University of Utah Medical School', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virgina Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Research Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53211', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': "Children's Hospital at Westmead", 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': 'V5Z 4E3', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'BC Cancer Agency', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Mary Horowitz, MD, MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Center for International Blood and Marrow Transplant Research'}]}, 'ipdSharingStatementModule': {'url': 'https://biolincc.nhlbi.nih.gov/home/', 'timeFrame': 'Within 6 months of official study closure at participating sites.', 'ipdSharing': 'YES', 'description': 'Findings were published in a manuscript.', 'accessCriteria': 'Available to the public.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'Blood and Marrow Transplant Clinical Trials Network', 'class': 'NETWORK'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'National Marrow Donor Program', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}