Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-26 @ 6:52 PM
Study NCT ID:
NCT03719534
Status:
COMPLETED
Last Update Posted:
2023-06-27
First Post:
2018-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Haplo HCT vs Haplo-cord HCT for Patients With AML
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-03-06', 'releaseDate': '2023-07-25'}, {'resetDate': '2024-10-11', 'releaseDate': '2024-07-15'}], 'estimatedResultsFirstSubmitDate': '2023-07-25'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 134}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-24', 'studyFirstSubmitDate': '2018-10-22', 'studyFirstSubmitQcDate': '2018-10-23', 'lastUpdatePostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '3 year after randomization', 'description': 'estimated overall survival at 3 year'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '3 year after randomization', 'description': 'estimated progression-free survival at 3 year'}, {'measure': 'Cumulative incidence of relapse', 'timeFrame': '3 year after randomization', 'description': 'estimated cumulative incidence of nonrelapse mortality at 3 year'}, {'measure': 'Cumulative incidence of non-relapse mortality', 'timeFrame': '3 year after randomization', 'description': 'estimated nonrelapse mortality at 3 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hematopoietic Stem Cell Transplantation', 'Haplo-identical Donor', 'Cord Blood Unit', 'Acute Myeloid Leukemia']}, 'referencesModule': {'references': [{'pmid': '38705885', 'type': 'DERIVED', 'citation': 'Zhou B, Chen J, Liu T, Ye Y, Zhang Y, Ding Y, Liu H, Zhu M, Ma X, Li X, Zhao L, Lin Z, Huang H, Xu Y, Wu D. Haploidentical hematopoietic cell transplantation with or without an unrelated cord blood unit for adult acute myeloid leukemia: a multicenter, randomized, open-label, phase 3 trial. Signal Transduct Target Ther. 2024 May 6;9(1):108. doi: 10.1038/s41392-024-01820-5.'}]}, 'descriptionModule': {'briefSummary': 'Patients who have acute myeloid leukemia and will undergo haplo-identical donor hematopoeitic cell transplantation (haplo HCT) are potential candidates of this trial. Participants will randomized into two arms: Arm A will undergo a typical haplo HCT, while Arm B will receive an coinfusion of an unrelated cord blood unit (haplo-cord HCT) in addition to Arm A. Progression-free survival, overall survival, cumulative incidence of relapse and nonrelapse mortality will be recorded as endpoints.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 18 to 60 years old;\n2. Patients with AML;\n3. With available minimal residual disease (MRD) parameters assessed by flow cytometry (FCM) and/or quantitative real-time PCR (qPCR)\n4. Having no available HLA-matched donor, and willing to undergo haplo-HCT and having a suitable haploidentical donor\n5. With Eastern Cooperative Oncology Group (ECOG) performance status of 0-3\n6. Signing informed consent form, having the ability to comply with study and follow-up procedures\n\nExclusion Criteria:\n\n1. Acute promyelocytic leukaemia (AML subtype M3)\n2. With other malignances\n3. Failing to acquire a suitable UCB unit\n4. With previous history of autologous haematopoietic cell transplantation (auto-HCT), allogeneic haematopoietic cell transplantation (allo-HCT) or chimaeric antigen receptor T-cell therapy\n5. With uncontrolled infection intolerant to haplo-HCT\n6. With severe organ dysfunction\n\n * Cardiac dysfunction (particularly congestive heart failure, unstable coronary artery disease and serious cardiac ventricular arrhythmias requiring antiarrhythmic therapy)\n * Respiratory failure (PaO2≤60 mmHg)\n * Hepatic abnormalities (total bilirubin≥2×upper limit of normal \\[ULN\\], alanine aminotransferase or aspartate aminotransferase≥2×ULN)\n * Renal dysfunction (creatinine≥2 mg/dL creatinine clearance rate \\< 30 mL/min)\n7. In pregnancy or lactation period\n8. With any conditions not suitable for the trial (investigators' decision)"}, 'identificationModule': {'nctId': 'NCT03719534', 'briefTitle': 'Haplo HCT vs Haplo-cord HCT for Patients With AML', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Soochow University'}, 'officialTitle': 'An Open-label, Multicenter, Randomized, Phase 3 Trial to Assess the Efficacy and Safety of Coinfusion With Unrelated Cord Blood Unit for Patients With Acute Myeloid Leukemia Undergoing Haploidentical Hematopoietic Cell Transplantation', 'orgStudyIdInfo': {'id': 'SZ3703'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Haplo-HCT', 'description': 'people enrolled in this arm will receive a typical haploidentical donor HCT', 'interventionNames': ['Procedure: haplo-HCT']}, {'type': 'EXPERIMENTAL', 'label': 'Haplo-cord HCT', 'description': 'people enrolled in this arm will receive a coinfusion of cord blood unit in addition to a typical haploidentical donor HCT', 'interventionNames': ['Procedure: haplo-cord HCT']}], 'interventions': [{'name': 'haplo-HCT', 'type': 'PROCEDURE', 'description': 'HCT will be performed with a haploidentical donor', 'armGroupLabels': ['Haplo-HCT']}, {'name': 'haplo-cord HCT', 'type': 'PROCEDURE', 'description': 'Haploidentical donor HCT will be performed with coinfusion of unrelated cord blood unit', 'armGroupLabels': ['Haplo-cord HCT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '223000', 'city': "Huai'an", 'state': 'Jiangsu', 'country': 'China', 'facility': "The Second People's Hospital of Huai'an", 'geoPoint': {'lat': 33.58861, 'lon': 119.01917}}, {'zip': '215006', 'city': 'Suzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The First Affiliated Hospital of Soochow University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'zip': '215100', 'city': 'Suzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Soochow Hopes Hematology Hospital', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'zip': '215200', 'city': 'Suzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Hygeia Suzhou Yongding Hospital', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The First Affiliated Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Depei Wu, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Soochow University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Soochow University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Zhejiang University', 'class': 'OTHER'}, {'name': "The Second People's Hospital of Huai'an", 'class': 'OTHER'}, {'name': 'Soochow Hopes Hematology Hospital', 'class': 'UNKNOWN'}, {'name': 'Hygeia Suzhou Yongding Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-07-25', 'type': 'RELEASE'}, {'date': '2024-03-06', 'type': 'RESET'}, {'date': '2024-07-15', 'type': 'RELEASE'}, {'date': '2024-10-11', 'type': 'RESET'}], 'unpostedResponsibleParty': 'The First Affiliated Hospital of Soochow University'}}}}