Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT02059720
Status:
UNKNOWN
Last Update Posted:
2020-02-05
First Post:
2014-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Haplo-SCT vs ASCT With or Without Decitabine in AML CR1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'ESTIMATED', 'count': 212}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-03', 'studyFirstSubmitDate': '2014-02-10', 'studyFirstSubmitQcDate': '2014-02-10', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality of Life', 'timeFrame': 'Five years', 'description': 'Including incidence and severity of acute and chronic GVHD, activity of daily living, psychological status, recovery of professional activity, social adaption, etc.'}], 'primaryOutcomes': [{'measure': 'Leukemia-Free Survival', 'timeFrame': 'Five years', 'description': 'Defined as the survival duration starting at the day of graft infusion, terminating at the day of death, morphological relapse or the end of follow-up.'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Five years', 'description': 'Defined as the survival duration starting at the day of graft infusion, terminating at the day of death or the end of follow-up.'}, {'measure': 'Cumulative relapse incidence', 'timeFrame': 'Five years', 'description': 'Defined as the cumulative incidence of morphological relapse after the day of graft infusion.'}, {'measure': 'Non-relapse Mortality', 'timeFrame': 'Five years', 'description': 'Defined as the cumulative incidence of death without cause of disease recurrence, which include the cause of GVHD, infection, hemorrhage, organic function failure, etc.'}, {'measure': 'Cumulative incidence of engraftment', 'timeFrame': '180 days', 'description': 'Defined as the cumulative incidence of durable complete donor chimerism detected by STR-PCR.'}]}, 'conditionsModule': {'keywords': ['acute myeloid leukemia', 'allogeneic hematopoietic stem cell transplantation', 'autologous hematopoietic stem cell transplantation', 'maintenance treatment', 'hematopoietic stem cell transplantation'], 'conditions': ['Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'A multicentre, prospective, open-label clinical study, including a randomized controlled study in low or intermediate-risk group patients, and a cohort study of maintenance treatment with decitabine after ASCT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\>= 18y\n* Diagnosed as AML (except acute promyelocytic leukemia M3) for the first time\n* Minimal Residual Disease (MRD) test can be achieved (molecular biology first if applicatable, and/or cytogenetics and/or immunophenotyping)\n* Presence of an available haplo-mismatch related donor\n\nExclusion Criteria:\n\n* Contra-indications of chemotherapy or hematopoietic stem cell transplantation\n* Presence of an available identical sibling donor or a 10/10 HLA loci-matched unrelated donor\n* Participating in other clinical trials concerning the prophylaxis of disease recurrence after ASCT\n* No effective contraception\n* Pregnant or lactating females\n* Other causes which are not suitable for the trial in investigator's consideration"}, 'identificationModule': {'nctId': 'NCT02059720', 'briefTitle': 'Haplo-SCT vs ASCT With or Without Decitabine in AML CR1', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Soochow University'}, 'officialTitle': 'Haplo-mismatch Donor Stem Cell Transplantation (SCT) Versus Autologous SCT Followed or Not by Maintenance Therapy, for Patients With Acute Myeloid Leukemia (AML) in First Remission: A Chinese Randomized Multicenter Study', 'orgStudyIdInfo': {'id': 'SZ3702'}, 'secondaryIdInfos': [{'id': 'ChiCTR-TRC-14004196', 'type': 'REGISTRY', 'domain': 'Chinese Clinical Trial Registry (ChiCTR)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'auto', 'description': 'patients receive autologous SCT', 'interventionNames': ['Procedure: HSCT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'haplo', 'description': 'patients receive haplo-SCT', 'interventionNames': ['Procedure: HSCT']}], 'interventions': [{'name': 'HSCT', 'type': 'PROCEDURE', 'description': 'Patients randomly assigned in to either of groups will receive either autologous SCT or haplo-SCT after CR1 is achieved.', 'armGroupLabels': ['auto', 'haplo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '215006', 'city': 'Suzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Depei Wu, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'wudepei@medmail.com.cn', 'phone': '+86 512 6778 1856'}, {'name': 'Jia Chen, M.D.', 'role': 'CONTACT', 'email': 'chenjia@suda.edu.cn', 'phone': '+86 512 6778 1856'}, {'name': 'Depei Wu, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jia Chen, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Aining Sun, M.D., Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Huiying Qiu, M.D., Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Xiaowen Tang, M.D., Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yue Han, M.D., Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Zhengming Jin, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Chengcheng Fu, M.D., Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Feng Chen, M.D., Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Xiao Ma, M.D., Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Suning Chen, M.D., Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Shengli Xue, M.D., Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Xiang Zhang, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The Fisrt Affiliated Hospital of Soochow University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}], 'centralContacts': [{'name': 'Depei Wu, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'wudepei@medmail.com.cn', 'phone': '+86 512 67781856'}, {'name': 'Jia Chen, M.D.', 'role': 'CONTACT', 'email': 'chenjia@suda.edu.cn', 'phone': '+86 512 67781856'}], 'overallOfficials': [{'name': 'Depei Wu, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Soochow University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Soochow University', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Society for Blood and Marrow Transplantation', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}