Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2026-02-23 @ 1:11 AM
Study NCT ID:
NCT02648932
Status:
TERMINATED
Last Update Posted:
2021-03-18
First Post:
2016-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Rapid Study: Randomized Phase II Study To Expedite Allogeneic Transplant With Immediate Haploidentical Plus Unrelated Cord Donor Search Versus Matched Unrelated Donor Search For AML And High-Risk MDS Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'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': 'D001855', 'term': 'Bone Marrow Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hliu2@medicine.bsd.uchicago.edu', 'phone': '773-834-0589', 'title': 'Hongtao Liu', 'organization': 'University of Chicago'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '100 days', 'eventGroups': [{'id': 'EG000', 'title': 'Haplo-Cord Search', 'description': 'If subject meets the inclusion criteria and consents, will undergo a haplo-cord transplant.\n\nHaplo-Cord Transplant: For conditioning regimens, haplo-identical grafts will be selected by the Miltenyi Device', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Matched Unrelated Donor Search (MUD)', 'description': 'If subject meets the inclusion criteria and consents, will undergo a MUD transplant.\n\nMatched Unrelated Donor Transplant', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 2, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oral hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Transplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Haplo-Cord Search', 'description': 'If subject meets the inclusion criteria and consents, will undergo a haplo-cord transplant.\n\nHaplo-Cord Transplant: For conditioning regimens, haplo-identical grafts will be selected by the Miltenyi Device'}, {'id': 'OG001', 'title': 'Matched Unrelated Donor Search (MUD)', 'description': 'If subject meets the inclusion criteria and consents, will undergo a MUD transplant.\n\nMatched Unrelated Donor Transplant'}], 'classes': [{'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000', 'lowerLimit': '63', 'upperLimit': '74'}, {'value': '111', 'groupId': 'OG001', 'lowerLimit': '68', 'upperLimit': '149'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Through one year after formal search', 'description': 'Time to transplant will be measured from time of date of formal request to stem cell infusion date. Will also capture time from preliminary search to both formal search and transplant date.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'We analyze only those who went to transplant.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Undergo Hematopoietic Cell Transplantation (HCT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Haplo-Cord Search', 'description': 'If subject meets the inclusion criteria and consents, will undergo a haplo-cord transplant.\n\nHaplo-Cord Transplant: For conditioning regimens, haplo-identical grafts will be selected by the Miltenyi Device'}, {'id': 'OG001', 'title': 'Matched Unrelated Donor Search (MUD)', 'description': 'If subject meets the inclusion criteria and consents, will undergo a MUD transplant.\n\nMatched Unrelated Donor Transplant'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through one year after formal search', 'description': 'Compare percentage of patients who undergo HCT in each study cohort', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Estimated Survival Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Haplo-Cord Search', 'description': 'If subject meets the inclusion criteria and consents, will undergo a haplo-cord transplant.\n\nHaplo-Cord Transplant: For conditioning regimens, haplo-identical grafts will be selected by the Miltenyi Device'}, {'id': 'OG001', 'title': 'Matched Unrelated Donor Search (MUD)', 'description': 'If subject meets the inclusion criteria and consents, will undergo a MUD transplant.\n\nMatched Unrelated Donor Transplant'}], 'classes': [{'title': 'Days from randomization', 'categories': [{'measurements': [{'value': '162', 'comment': 'There are not enough people have died yet to estimate the upper confidence interval. One of two participants survived.', 'groupId': 'OG000', 'lowerLimit': '162', 'upperLimit': 'NA'}, {'value': '785', 'comment': 'There are not enough people have died yet to estimate the upper confidence interval. One of three participants survived.', 'groupId': 'OG001', 'lowerLimit': '607', 'upperLimit': 'NA'}]}]}, {'title': 'Days from transplant', 'categories': [{'measurements': [{'value': '92', 'comment': 'There are not enough people have died yet to estimate the upper confidence interval. One of two participants survived.', 'groupId': 'OG000', 'lowerLimit': '92', 'upperLimit': 'NA'}, {'value': '673', 'comment': 'There are not enough people have died yet to estimate the upper confidence interval. One of three participants survived.', 'groupId': 'OG001', 'lowerLimit': '467', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization up to 3 years', 'description': 'Overall survival time was estimated from date of randomization and from date of transplant using Kaplan-Meier method.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'We analyzed only those who went transplant.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Haplo-Cord Search', 'description': 'If subject meets the inclusion criteria and consents, will undergo a haplo-cord transplant.\n\nHaplo-Cord Transplant: For conditioning regimens, haplo-identical grafts will be selected by the Miltenyi Device'}, {'id': 'FG001', 'title': 'Matched Unrelated Donor Search (MUD)', 'description': 'If subject meets the inclusion criteria and consents, will undergo a MUD transplant.\n\nMatched Unrelated Donor Transplant'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'No transplant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Haplo-Cord Search', 'description': 'If subject meets the inclusion criteria and consents, will undergo a haplo-cord transplant.\n\nHaplo-Cord Transplant: For conditioning regimens, haplo-identical grafts will be selected by the Miltenyi Device'}, {'id': 'BG001', 'title': 'Matched Unrelated Donor Search (MUD)', 'description': 'If subject meets the inclusion criteria and consents, will undergo a MUD transplant.\n\nMatched Unrelated Donor Transplant'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.9', 'groupId': 'BG000', 'lowerLimit': '53.5', 'upperLimit': '71.9'}, {'value': '61.2', 'groupId': 'BG001', 'lowerLimit': '53', 'upperLimit': '66.8'}, {'value': '62.1', 'groupId': 'BG002', 'lowerLimit': '53', 'upperLimit': '71.9'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', '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': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-02-16', 'size': 439629, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-02-10T22:55', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'Poor accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-22', 'studyFirstSubmitDate': '2016-01-04', 'resultsFirstSubmitDate': '2021-02-22', 'studyFirstSubmitQcDate': '2016-01-06', 'lastUpdatePostDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-22', 'studyFirstPostDateStruct': {'date': '2016-01-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Transplant', 'timeFrame': 'Through one year after formal search', 'description': 'Time to transplant will be measured from time of date of formal request to stem cell infusion date. Will also capture time from preliminary search to both formal search and transplant date.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients Who Undergo Hematopoietic Cell Transplantation (HCT)', 'timeFrame': 'Through one year after formal search', 'description': 'Compare percentage of patients who undergo HCT in each study cohort'}, {'measure': 'Estimated Survival Time', 'timeFrame': 'From date of randomization up to 3 years', 'description': 'Overall survival time was estimated from date of randomization and from date of transplant using Kaplan-Meier method.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute Myeloid Leukemia (AML)', 'High-Risk Myelodysplastic Syndrome (MDS)', 'hematopoietic cell transplantation', 'haplo-cord search', 'matched unrelated donor search'], 'conditions': ['Acute Myeloid Leukemia (AML)', 'Myelodysplastic Syndrome (MDS)']}, 'descriptionModule': {'briefSummary': 'The study seeks to compare time from formal search to hematopoietic cell transplantation (HCT) for patients 18 years and older, randomized between haplo-cord search and matched unrelated donor (MUD) search for patients with acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS)', 'detailedDescription': 'Primary Objectives\n\nTo compare time from formal search to hematopoietic cell transplantation (HCT) for patients 18 years and older, randomized between haplo-cord search and matched unrelated donor (MUD) search for patients with acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS)\n\nSecondary Objectives\n\n* To compare the percentage of patients who undergo HCT in each study cohort\n* To evaluate overall survival from time to randomization by study cohort'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria for Search Phase:\n\n1. Diagnosis of acute myeloid leukemia (AML) or high or very high-risk MDS by international prognostic scoring system revised for whom transplant is recommended\n2. 18 years of age or older\n3. Subject is likely to be considered for allogeneic transplant in the opinion of the transplant physician (based on age of patient, health, cytogenetics, and/or molecular characteristics).\n4. Karnofsky Performance Status (KPS) \\>/= 70% at time of enrollment. An exception will be made for those with lower KPS at enrollment with an acute worsening that is likely to resolve in the treating physicians judgment (e.g., reversible infection,trauma, medication reaction, etc)\n5. Ability to understand and the willingness to sign a written informed consent document for the Search Phase.\n6. Patient willing to consider HCT\n7. A preliminary search has identified:\n\n 1. An appropriate minimum 4/6 matched umbilical cord unit at intermediate resolution at HLA-A and B, and high resolution at HLA-DRB with a cell dose above 1 x 10(7) TNC/kg for a single umbilical cord blood (UCB) transplant AND\n 2. At least one potential 8/8 HLA-matched (HLA-A, -B, -C, and -DRB1) unrelated donor with a probability of 70% AND\n 3. Availability of a potential related haploidentical donor.\n\nExclusion Criteria for Search Phase:\n\n1. Prior formal search was instituted\n2. Diagnosis of acute promyelocytic leukemia (APL)\n3. Known HLA matched related donor without contraindications to donate\n4. Life expectancy severely limited by concomitant illness or uncontrolled infection\n\nInclusion Criteria for Transplant Phase\n\n1. High-risk AML for which transplant is recommend based on cytogenetic, molecular and morphologic features. Patients must meet institutional standards for disease control prior to transplant.\n2. For MDS. IPSS-revised criteria of high or very high at diagnosis.\n3. Subject meets institutional criteria for transplant and has acceptable organ and marrow function as defined below:\n\n 1. Serum bilirubin \\< 2.0mg/dL unless Gilberts disease\n 2. Creatinine Clearance \\> 45 mL/min.1.73m2 as estimated by modified MDRD equation\n 3. Left ventricular function 40% or greater\n 4. DLCO corrected for hemoglobin \\>50%\n 5. KPS 70% or greater\n4. An adequate graft for the defined donor type\n\n 1. Haplo-cord requires a haploidentical adult donor of 14 years of age and at least 50 kg, and a cord blood unit with at least 1.0 x 10(7) TNC/kg and a match of at least 4/6 by intermediate resolution for HLA-A and B and high resolution at DRB1. Donor provides standard of care consent for harvest following institutional policy. Any donor samples or donor research data would be obtained on separate donor research protocol.\n 2. For MUD requires a 7/8 or 8/8 HLA matched unrelated donor with high resolution matching at HLA-A, -B, -C, and DRB1. DP matching or DP permissive should be achieved when possible using T-cell epitope strategy.\n5. Written informed consent for the transplant phase\n\nExclusion Criteria for Transplant Phase\n\n1. Life expectancy severely limited by concomitant illness or uncontrolled infection\n2. HIV-positive'}, 'identificationModule': {'nctId': 'NCT02648932', 'briefTitle': 'The Rapid Study: Randomized Phase II Study To Expedite Allogeneic Transplant With Immediate Haploidentical Plus Unrelated Cord Donor Search Versus Matched Unrelated Donor Search For AML And High-Risk MDS Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'The Rapid Study: Randomized (RA) Phase (P) II Study To Expedite Allogeneic Transplant With Immediate (I) Haploidentical Plus Unrelated Cord Donor (D) Search Versus Matched Unrelated Donor Search For AML And High-Risk MDS Patients', 'orgStudyIdInfo': {'id': 'IRB15-0866'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Haplo-Cord Search', 'description': 'If subject meets the inclusion criteria and consents, will undergo a haplo-cord transplant.', 'interventionNames': ['Biological: Haplo-Cord Transplant']}, {'type': 'OTHER', 'label': 'Matched Unrelated Donor Search (MUD)', 'description': 'If subject meets the inclusion criteria and consents, will undergo a MUD transplant.', 'interventionNames': ['Procedure: Matched Unrelated Donor Transplant']}], 'interventions': [{'name': 'Haplo-Cord Transplant', 'type': 'BIOLOGICAL', 'description': 'For conditioning regimens, haplo-identical grafts will be selected by the Miltenyi Device', 'armGroupLabels': ['Haplo-Cord Search']}, {'name': 'Matched Unrelated Donor Transplant', 'type': 'PROCEDURE', 'armGroupLabels': ['Matched Unrelated Donor Search (MUD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Cancer Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Andrew Artz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}