Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2026-02-22 @ 5:09 PM
Study NCT ID:
NCT02028650
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
2014-01-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Study of HLA-mismatched DSI to Treat Relapse Leukemia After HLA- Matched Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'the blood and bone marrow samples before and after transplantation and DSI'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-12', 'studyFirstSubmitDate': '2014-01-01', 'studyFirstSubmitQcDate': '2014-01-04', 'lastUpdatePostDateStruct': {'date': '2016-07-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with graft versus host diseases', 'timeFrame': '100 days'}], 'secondaryOutcomes': [{'measure': 'Time to Disease Progression', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['relapse leukemia', 'DSI'], 'conditions': ['Relapse Leukemia']}, 'descriptionModule': {'briefSummary': 'The relapse leukemia patients after transplantation were divided into two groups randomly. Group D1: patients received first-donor stem cells infusion(DSI) treatment with or without chemotherapy; group D2: patients received second-donor DSI treatment with or without chemotherapy. The second donors were preferably donors who were genetically related and had more HLA-match locus. The re-induction chemotherapy regimen was primarily MAT(mitoxantrone, cytarabine, Teniposide ) for acute myeloid leukemia (AML) and VMCLD(vincristine, Teniposide, cyclophosphamide, L-Asparaginase, Dexamethasone) for acute lymphocytic leukemia (ALL), and no graft versus host disease(GVHD) prevention was conducted pre- and post- therapy.', 'detailedDescription': 'Evaluation indications include bone marrow morphology,hematopoietic recovery (neutrophil and platelet), 100-day transplantation-related mortality (TRM), donor chimerism, acute GVHD, chronic GVHD, disease free survival (DFS), and overall survival (OS). The cut-time of the follow-up was Oct, 2013. DFS was defined as the time between the date of transplantation to the death or relapse. OS was defined as the time from diagnosis to death or to the last date of follow-up until Oct. 2013.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '67 Years', 'minimumAge': '9 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Eligible patients were between 9 and 67 years of age with de novo diagnosed or treated-related Acute leukemia relapsed after HLA-matched hematological stem cell transplantation from Feb 2005 to Feb 2013.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible patients were between 9 and 67 years of age with de novo diagnosed or treated-related Acute leukemia relapsed after HLA-matched hematological stem cell transplantation from Feb 2005 to Feb 2013\n* Relapse was morphologically and molecularly diagnosed,with the help of cytogenetic and engraftment.\n* Eastern Cooperative Oncology Group (ECOG) performance status was 0 to 2\n\nExclusion Criteria:\n\n* Patients without receiving CR will not receive further post-remission trial therapy\n* The patients of AML-M3 were excluded from this study.'}, 'identificationModule': {'nctId': 'NCT02028650', 'briefTitle': 'Randomized Study of HLA-mismatched DSI to Treat Relapse Leukemia After HLA- Matched Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Hospital of the Chinese Academy of Military Medical Sciences'}, 'officialTitle': 'HLA-mismatched Peripheral Hematopoietic Stem Cells Infusion in the Treatment of Leukemia Patients Relapse After HLA- Matched Allogeneic Stem Cell Transplantation: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'RL13-307PLAH-AHS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'the first donor', 'description': "the original donor applicable patients were assigned to receive the first donor's stem cell treatment after G-CSF mobilization or combination chemotherapy", 'interventionNames': ["Biological: the first donor's stem cell"]}, {'label': 'the second donor', 'description': "HLA-mismatched, the second donor's stem cell infusion", 'interventionNames': ["Biological: the second donor's stem cell"]}], 'interventions': [{'name': "the first donor's stem cell", 'type': 'BIOLOGICAL', 'description': 'HLA-matched stem cell infusion', 'armGroupLabels': ['the first donor']}, {'name': "the second donor's stem cell", 'type': 'BIOLOGICAL', 'description': "HLA-mismatched, the second donor's stem cell infusion", 'armGroupLabels': ['the second donor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100071', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Affiliated Hospital of Academy of Military Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'qiao jianhui, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Affiliated Hospital of Academy of Military Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'huishengai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'director of Hematology Department', 'investigatorFullName': 'huishengai', 'investigatorAffiliation': 'The Affiliated Hospital of the Chinese Academy of Military Medical Sciences'}}}}