Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 11:00 PM
Study NCT ID:
NCT00406393
Status:
COMPLETED
Last Update Posted:
2023-01-04
First Post:
2006-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Sirolimus/Tacrolimus Versus Tacrolimus/Methotrexate for Preventing Graft-Versus-Host Disease (GVHD) (BMT CTN 0402)
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'}], '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': 'D016559', 'term': 'Tacrolimus'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D020123', 'term': 'Sirolimus'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amendizabal@emmes.com', 'phone': '301-251-1161', 'title': 'Adam Mendizabal, PhD', 'organization': 'The Emmes Corporation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '2-years post transplant', 'description': 'Serious adverse events 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.', 'eventGroups': [{'id': 'EG000', 'title': 'Tacrolimus/Sirolimus', 'description': 'Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.', 'otherNumAtRisk': 149, 'otherNumAffected': 0, 'seriousNumAtRisk': 149, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Tacrolimus/Methotrexate', 'description': 'Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.', 'otherNumAtRisk': 152, 'otherNumAffected': 0, 'seriousNumAtRisk': 152, 'seriousNumAffected': 12}], 'seriousEvents': [{'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Thoracotomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Retinal tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'VIIth nerve paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Myositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of Grades II-IV Acute GVHD-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tacrolimus/Sirolimus', 'description': 'Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.'}, {'id': 'OG001', 'title': 'Tacrolimus/Methotrexate', 'description': 'Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.'}], 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000', 'lowerLimit': '59', 'upperLimit': '74'}, {'value': '62', 'groupId': 'OG001', 'lowerLimit': '54', 'upperLimit': '70'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 114', 'description': 'The primary objective is to compare rates of 114-day Grades II-IV acute GVHD-free survival post randomization for HLA-matched, related donor allogeneic peripheral blood stem cell transplantation using two different GVHD prophylaxis regimens. Participants are graded on a scale of 1 to 4 according to their symptoms and organs involved, where 4 represents a worse grade.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Acute GVHD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tacrolimus/Sirolimus', 'description': 'Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.'}, {'id': 'OG001', 'title': 'Tacrolimus/Methotrexate', 'description': 'Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '34'}, {'value': '34', 'groupId': 'OG001', 'lowerLimit': '26', 'upperLimit': '41'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured at Day 100', 'description': 'Cumulative incidence of acute GVHD (grade II-IV) occurring 100 days from transplantation.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Neutrophil and Platelet Engraftment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tacrolimus/Sirolimus', 'description': 'Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.'}, {'id': 'OG001', 'title': 'Tacrolimus/Methotrexate', 'description': 'Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.'}], 'classes': [{'title': 'Neutrophil Engraftment', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '27'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '68'}]}]}, {'title': 'Platelet Engraftment', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '100'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '100'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Measured through Day 100', 'description': 'Neutrophil engraftment is defined as achieving an Absolute Neutrophil Count (ANC) \\> 500/mcL for three consecutive measurements on different days. Platelet engraftment is defined as a platelet count \\> 20,000/mcL for three consecutive measurements over three or more days.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mucositis Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tacrolimus/Sirolimus', 'description': 'Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.'}, {'id': 'OG001', 'title': 'Tacrolimus/Methotrexate', 'description': 'Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.31', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0.47', 'spread': '0.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Day 21', 'description': 'Mucositis severity will be scored per the modified Oral Mucositis Assessment Scale (OMAS) scoring system on a scale of 0 - 4, where 0 equals normal mucosa and 4 represents severe mucosa.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Veno-occlusive Disease (VOD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tacrolimus/Sirolimus', 'description': 'Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.'}, {'id': 'OG001', 'title': 'Tacrolimus/Methotrexate', 'description': 'Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '16'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured through Day 100', 'description': 'VOD will be defined as the occurrence of VOD (based on the Baltimore Criteria for the diagnosis of VOD) in conjunction with other end-organ dysfunction.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Thrombotic Microangiopathy (TMA) Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tacrolimus/Sirolimus', 'description': 'Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.'}, {'id': 'OG001', 'title': 'Tacrolimus/Methotrexate', 'description': 'Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '10'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured through Day 100', 'description': 'The occurrence of TMA within the first 100 days after stem cell transplantation will be recorded. The first day of onset will be used for reporting purposes.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Reactivation of Cytomegalovirus (CMV) Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tacrolimus/Sirolimus', 'description': 'Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.'}, {'id': 'OG001', 'title': 'Tacrolimus/Methotrexate', 'description': 'Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '19'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '21'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured at Year 2', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Treatment-related Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tacrolimus/Sirolimus', 'description': 'Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.'}, {'id': 'OG001', 'title': 'Tacrolimus/Methotrexate', 'description': 'Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.'}], 'classes': [{'title': 'Day 100', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '11'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '12'}]}]}, {'title': 'Year 2', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '26'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '23'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured at Day 100 and Year 2', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Malignant Disease Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tacrolimus/Sirolimus', 'description': 'Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.'}, {'id': 'OG001', 'title': 'Tacrolimus/Methotrexate', 'description': 'Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '35'}, {'value': '29', 'groupId': 'OG001', 'lowerLimit': '22', 'upperLimit': '37'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured at Year 2', 'description': 'Testing for recurrent malignancy in the blood, marrow or other sites will be used to assess relapse after transplantation. For the purpose of this study, relapse is defined by either morphological or cytogenetic evidence of AML, ALL, CML, MDS or CMML consistent with pre-transplant features.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tacrolimus/Sirolimus', 'description': 'Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.'}, {'id': 'OG001', 'title': 'Tacrolimus/Methotrexate', 'description': 'Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000', 'lowerLimit': '51', 'upperLimit': '67'}, {'value': '63', 'groupId': 'OG001', 'lowerLimit': '55', 'upperLimit': '70'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Measured at Year 2', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tacrolimus/Sirolimus', 'description': 'Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.'}, {'id': 'OG001', 'title': 'Tacrolimus/Methotrexate', 'description': 'Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.'}], 'timeFrame': 'Measured at Year 2', 'reportingStatus': 'POSTED', 'populationDescription': 'Insufficient data to report on this outcome measure'}, {'type': 'SECONDARY', 'title': 'Time to Discharge After Transplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tacrolimus/Sirolimus', 'description': 'Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.'}, {'id': 'OG001', 'title': 'Tacrolimus/Methotrexate', 'description': 'Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.'}], 'timeFrame': 'Measured at Year 2', 'reportingStatus': 'POSTED', 'populationDescription': 'Insufficient data to report on this outcome measure'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tacrolimus/Sirolimus', 'description': 'Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.'}, {'id': 'FG001', 'title': 'Tacrolimus/Methotrexate', 'description': 'Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '151'}, {'groupId': 'FG001', 'numSubjects': '153'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '149'}, {'groupId': 'FG001', 'numSubjects': '152'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Did not undergo transplantation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled from 2006 to 2011 from 24 different transplant centers.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '304', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tacrolimus/Sirolimus', 'description': 'Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.'}, {'id': 'BG001', 'title': 'Tacrolimus/Methotrexate', 'description': 'Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '59'}, {'value': '43', 'groupId': 'BG001', 'lowerLimit': '13', 'upperLimit': '58'}, {'value': '44', 'groupId': 'BG002', 'lowerLimit': '13', 'upperLimit': '59'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '162', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Primary Disease', 'classes': [{'title': 'Acute Myelogenous Leukemia (AML)', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}]}, {'title': 'Acute Lymphoblastic Leukemia (ALL)', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}]}, {'title': 'Chronic Myelogenous Leukemia (CML)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Myelodysplastic Syndrome (MDS)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Acute Biphenotypic Leukemia (ABL)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Disease Status at Transplantation', 'classes': [{'title': 'AML 1st Complete Remission', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}]}, {'title': 'AML 2nd Complete Remission', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'ALL 1st Complete Remission', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}, {'title': 'ALL 2nd Complete Remission', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'CML 1st Complete Remission', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'CML 2nd Complete Remission', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'ABL 1st Complete Remission', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'MDS', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Karnofsky Score', 'classes': [{'title': 'Scores 90 - 100', 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '217', 'groupId': 'BG002'}]}]}, {'title': 'Scores < 90', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', '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-Donor Cytomegalovirus Status', 'classes': [{'title': '+/+', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}]}, {'title': '+/-', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': '-/+', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}, {'title': '-/-', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Seropositivity (+) or Seronegativity (-) for the recipient / Seropositivity (+) or Seronegativity (-) for the donor', 'unitOfMeasure': 'participants'}, {'title': 'Conditioning Regimen', 'classes': [{'title': 'Cyclophosphamide/Total Body Irradiation', 'categories': [{'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '246', 'groupId': 'BG002'}]}]}, {'title': 'Etoposide/Total Body Irradiation', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2010-12-03', 'size': 994720, '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': '2022-11-29T12:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 304}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-07', 'studyFirstSubmitDate': '2006-11-30', 'resultsFirstSubmitDate': '2016-01-06', 'studyFirstSubmitQcDate': '2006-11-30', 'lastUpdatePostDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-02-08', 'studyFirstPostDateStruct': {'date': '2006-12-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Grades II-IV Acute GVHD-free Survival', 'timeFrame': 'Day 114', 'description': 'The primary objective is to compare rates of 114-day Grades II-IV acute GVHD-free survival post randomization for HLA-matched, related donor allogeneic peripheral blood stem cell transplantation using two different GVHD prophylaxis regimens. Participants are graded on a scale of 1 to 4 according to their symptoms and organs involved, where 4 represents a worse grade.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Acute GVHD', 'timeFrame': 'Measured at Day 100', 'description': 'Cumulative incidence of acute GVHD (grade II-IV) occurring 100 days from transplantation.'}, {'measure': 'Time to Neutrophil and Platelet Engraftment', 'timeFrame': 'Measured through Day 100', 'description': 'Neutrophil engraftment is defined as achieving an Absolute Neutrophil Count (ANC) \\> 500/mcL for three consecutive measurements on different days. Platelet engraftment is defined as a platelet count \\> 20,000/mcL for three consecutive measurements over three or more days.'}, {'measure': 'Mucositis Severity', 'timeFrame': 'Measured at Day 21', 'description': 'Mucositis severity will be scored per the modified Oral Mucositis Assessment Scale (OMAS) scoring system on a scale of 0 - 4, where 0 equals normal mucosa and 4 represents severe mucosa.'}, {'measure': 'Rate of Veno-occlusive Disease (VOD)', 'timeFrame': 'Measured through Day 100', 'description': 'VOD will be defined as the occurrence of VOD (based on the Baltimore Criteria for the diagnosis of VOD) in conjunction with other end-organ dysfunction.'}, {'measure': 'Thrombotic Microangiopathy (TMA) Infection', 'timeFrame': 'Measured through Day 100', 'description': 'The occurrence of TMA within the first 100 days after stem cell transplantation will be recorded. The first day of onset will be used for reporting purposes.'}, {'measure': 'Reactivation of Cytomegalovirus (CMV) Infection', 'timeFrame': 'Measured at Year 2'}, {'measure': 'Treatment-related Mortality', 'timeFrame': 'Measured at Day 100 and Year 2'}, {'measure': 'Malignant Disease Relapse', 'timeFrame': 'Measured at Year 2', 'description': 'Testing for recurrent malignancy in the blood, marrow or other sites will be used to assess relapse after transplantation. For the purpose of this study, relapse is defined by either morphological or cytogenetic evidence of AML, ALL, CML, MDS or CMML consistent with pre-transplant features.'}, {'measure': 'Overall Survival', 'timeFrame': 'Measured at Year 2'}, {'measure': 'Infections', 'timeFrame': 'Measured at Year 2'}, {'measure': 'Time to Discharge After Transplant', 'timeFrame': 'Measured at Year 2'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acute Myelogenous Leukemia', 'Acute Lymphoblastic Leukemia', 'Chronic Myelogenous Leukemia'], 'conditions': ['Leukemia, Myelocytic, Acute', 'Leukemia, Lymphocytic, Acute', 'Leukemia, Myeloid, Chronic', 'Myelodysplastic Syndromes']}, 'referencesModule': {'references': [{'pmid': '24982504', 'type': 'RESULT', 'citation': 'Cutler C, Logan B, Nakamura R, Johnston L, Choi S, Porter D, Hogan WJ, Pasquini M, MacMillan ML, Hsu JW, Waller EK, Grupp S, McCarthy P, Wu J, Hu ZH, Carter SL, Horowitz MM, Antin JH. Tacrolimus/sirolimus vs tacrolimus/methotrexate as GVHD prophylaxis after matched, related donor allogeneic HCT. Blood. 2014 Aug 21;124(8):1372-7. doi: 10.1182/blood-2014-04-567164. Epub 2014 Jun 30.'}]}, 'descriptionModule': {'briefSummary': 'The study is designed as a phase III, randomized, open label, multicenter, prospective, comparative trial of sirolimus and tacrolimus versus tacrolimus and methotrexate as graft-versus-host disease (GVHD) prophylaxis after human leukocyte antigen (HLA)-matched, related, peripheral blood stem cell transplantation in individuals with hematologic cancer. Participants will be stratified by transplant center and will be randomly assigned to the sirolimus/tacrolimus or tacrolimus/methotrexate arms at a 1:1 ratio.', 'detailedDescription': "BACKGROUND:\n\nStem cell transplantation is a standard therapy for acute and chronic leukemias and myelodysplastic disorders. A common problem that may occur after a stem cell transplant is a condition known as GVHD. The purpose of this study is to compare two combinations of medications to see which is better at preventing GVHD. The combinations of medications in this study are:\n\n* Sirolimus and tacrolimus\n* Methotrexate and tacrolimus\n\nDoctors want to know if one combination is better than the other or if they both have the same result.\n\nDESIGN NARRATIVE:\n\nParticipants will receive one of the two conditioning regimens described in the protocol, at the discretion of the transplant physician. The transplant physician must choose among these regimens prior to the participant's assignment to the GVHD prophylaxis treatment. Conditioning regimens will vary by center, but will be the same for all participants at each center. Stem cell donors will donate peripheral blood stem cells according to local institutional practices. Peripheral blood stem cells will not be manipulated or T-depleted prior to administration. Standard post-transplant care will be administered. Participants will be randomly assigned to one of two GVHD prophylaxis regimens and will be followed for the endpoints of interest.\n\nParticipants will be followed for 114 days post-randomization for evaluation of the primary endpoint, with additional follow-up for 2 years after transplantation for evaluation of secondary endpoints."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 6/6 HLA-matched sibling, defined by Class I (HLA-A and B) serologic typing (or higher resolution) and Class II (HLA-DRBI) molecular typing, who is willing to donate peripheral blood stem cells, and meets institutional criteria for stem cell donation. The donor must be medically eligible to donate stem cells, according to individual transplant center criteria. Pediatric patients for whom a pediatric sibling donor is not anticipated to be a suitable leukapheresis candidate are not eligible.\n* Karnofsky performance status of at least 70% or Lansky performance status of at least 70% for participants less than 16 years old\n* For participants less than 18 years old, willing and able to take oral medications, per the treating physician's recommendations\n\nExclusion Criteria:\n\n* Prior allogeneic or autologous transplant using any hematopoietic stem cell source\n* Seropositive for the human immunodeficiency virus (HIV)\n* Uncontrolled bacterial, viral, or fungal infection (currently taking medication and progression of clinical symptoms)\n* Pregnant (positive serum human chorionic gonadotropin \\[β-HCG\\] test) or breastfeeding within 4 weeks of study entry\n* Kidney function: serum creatinine outside the normal range for age, or measured creatinine clearance less than 50 mL/min/1.72m\\^2 within 4 weeks of study entry\n* Liver function: most recent direct bilirubin, alanine aminotransferase (ALT), or aspartate aminotransferase (AST) greater than two times the upper limit of normal within 4 weeks of study entry\n* Lung disease: in adults, forced vital capacity (FVC) or forced expiratory volume in one second (FEV1) less than 60% of predicted value (corrected for hemoglobin); in children, overt hypoxemia, as measured by an oxygen saturation of less than 92% within 4 weeks of study entry\n* Cardiac ejection fraction of less than 45% in adults and children, or less than 26% shortening fraction in children within 4 weeks of study entry\n* Cholesterol level greater than 500 mg/dL or triglyceride level greater than 500 mg/dL while being treated, or not on appropriate lipid-lowering therapy within 4 weeks of study entry\n* Prior history of allergy to sirolimus\n* Requires voriconazole at time of study entry\n* Currently receiving another investigational drug unless cleared by the protocol officer or protocol chair\n* Participants with a history of cancer, other than resected basal cell carcinoma or treated carcinoma in-situ. Cancer treated with curative intent for more than 5 years previously will be allowed. Cancer treated with curative intent for less than 5 years previously will not be allowed unless approved by the protocol officer or protocol chair."}, 'identificationModule': {'nctId': 'NCT00406393', 'briefTitle': 'Sirolimus/Tacrolimus Versus Tacrolimus/Methotrexate for Preventing Graft-Versus-Host Disease (GVHD) (BMT CTN 0402)', 'organization': {'class': 'OTHER', 'fullName': 'Medical College of Wisconsin'}, 'officialTitle': 'A Phase III Randomized, Multicenter Trial Comparing Sirolimus/Tacrolimus With Tacrolimus/Methotrexate as Graft-versus-Host Disease (GVHD) Prophylaxis After HLA-Matched, Related Peripheral Blood Stem Cell Transplantation (BMT CTN #0402)', 'orgStudyIdInfo': {'id': 'BMTCTN0402'}, 'secondaryIdInfos': [{'id': 'U01HL069294', 'link': 'https://reporter.nih.gov/quickSearch/U01HL069294', 'type': 'NIH'}, {'id': 'BMT CTN 0402', 'type': 'OTHER', 'domain': 'Blood and Marrow Transplant Clinical Trials Network'}, {'id': 'U01HL069294-05', 'link': 'https://reporter.nih.gov/quickSearch/U01HL069294-05', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tacrolimus/Methotrexate', 'description': 'Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.', 'interventionNames': ['Drug: Tacrolimus', 'Drug: Methotrexate']}, {'type': 'EXPERIMENTAL', 'label': 'Tacrolimus/Sirolimus', 'description': 'Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.', 'interventionNames': ['Drug: Tacrolimus', 'Drug: Sirolimus']}], 'interventions': [{'name': 'Tacrolimus', 'type': 'DRUG', 'otherNames': ['Prograf®', 'FK506'], 'description': 'Adults and Children: Tacrolimus will be given at a dose of 0.02 mg/kg every 24 hours as a continuous intravenous infusion beginning on Day -3. An effort will be made to convert the tacrolimus to oral dosing at 2-3 times the total 24-hour intravenous dose, split into 2 doses given every 12 hours as soon as clinically feasible.\n\nThe target serum level for tacrolimus is 5-10 ng/mL.', 'armGroupLabels': ['Tacrolimus/Methotrexate', 'Tacrolimus/Sirolimus']}, {'name': 'Methotrexate', 'type': 'DRUG', 'otherNames': ['MTX'], 'description': 'Methotrexate will be given at a dose of 15 mg/m2 on Day 1 after transplantation, and at a dose of 10 mg/m2 on Days 3, 6 and 11 after transplantation.', 'armGroupLabels': ['Tacrolimus/Methotrexate']}, {'name': 'Sirolimus', 'type': 'DRUG', 'otherNames': ['Rapamycin', 'Rapamune'], 'description': 'Adults: Sirolimus will be given in a loading dose of 12 mg on Day -3 followed by a daily oral dose of 4 mg per day. Doses may be repeated if the subject vomits within 15 minutes of an oral dose.\n\nChildren: Children aged \\< 12.0 years OR weighing \\< 40.0 kg will be given an oral loading dose of sirolimus of 3 mg/m2 followed by a daily oral dose of 1 mg/m2, rounded to the nearest full milligram.\n\nThe target serum level for sirolimus is 3-12 ng/mL.', 'armGroupLabels': ['Tacrolimus/Sirolimus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope National Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UCSD Medical Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Hospital and Clinics', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'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': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', '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': '52242-1009', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "DFCI/Brigham & Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109-0914', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Medical Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University/Barnes Jewish Hospital', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44106-5061', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals of Cleveland/Case Western', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State, Arthur G. James Cancer Hospital', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma Medical Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Cancer Institute', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Transplant Institute', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University/MCV Hospital', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '53792-5156', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Hospital & Clinics', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': 'CEDEX 10', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Saint-Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Mary Horowitz, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Center for International Blood and Marrow Transplant Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Findings will be published in a manuscript.'}, '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'}], 'responsibleParty': {'type': 'SPONSOR'}}}}