Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-01-10 @ 2:54 PM
Study NCT ID:
NCT03663751
Status:
COMPLETED
Last Update Posted:
2021-05-21
First Post:
2018-09-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low-dose Decitabine for the Treatment of Decreased Donor Chimerism After Allogeneic Stem Cell Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077209', 'term': 'Decitabine'}], 'ancestors': [{'id': 'D001374', 'term': 'Azacitidine'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-19', 'studyFirstSubmitDate': '2018-09-06', 'studyFirstSubmitQcDate': '2018-09-06', 'lastUpdatePostDateStruct': {'date': '2021-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete response rate', 'timeFrame': '6 months after initiation of treatment', 'description': 'Documentation \\>98% donor chimerism of T cells or mononuclear cell in either peripheral blood or bone marrow'}], 'secondaryOutcomes': [{'measure': 'relapse rate', 'timeFrame': '12 months after initiation of treatment', 'description': 'Documentation of blast in bone marrow \\>5%'}, {'measure': 'engraftment failure', 'timeFrame': '12 months after initiation of treatment', 'description': 'Documentation of pancytopenia with donor chimerism \\<5%'}, {'measure': 'survival rate', 'timeFrame': '12 months after initiation of treatment', 'description': 'event counted as death due to any cause'}, {'measure': 'incidence of grade III-IV aGVHD', 'timeFrame': '12 months after initiation of treatment', 'description': 'event counted as documentation of new onset or aggravation of pre-existing aGVHD into grade III-IV'}, {'measure': 'incidence of moderate to severe chronic GVHD', 'timeFrame': '12 months after initiation of treatment', 'description': 'event counted as documentation of moderate to severe chronic GVHD'}, {'measure': 'Overall response', 'timeFrame': '6 months after initiation of treatment', 'description': 'Documentation of complete or partial response'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['donor chimerism,', 'decitabine,', 'allo-HSCT'], 'conditions': ['Response Rate']}, 'descriptionModule': {'briefSummary': 'Decreasing donor chimerism is considered as an early sign of graft failure or relapse in patients undergoing allogeneic stem cell transplantation. The treatment option included tapering or stop of immunosuppression and or donor lymphocyte infusion (DLI) which may restore a full donor chimerism but subsequent graft versus host disease (GVHD) is the major complications. In this single arm prospective study, the investigator evaluate the effect and safety of low-dose decitabine alone or with DLI in patients with decreased donor chimerism after allo-HSCT.', 'detailedDescription': 'Decreasing donor chimerism is considered as an early sign of graft failure or relapse in patients undergoing allogeneic stem cell transplantation. The treatment option included tapering or stop of immunosuppression and or donor lymphocyte infusion (DLI) which may restore a full donor chimerism but subsequent GVHD is the major complications. In this single arm prospective study, the investigator plan to evaluate the effect and safety of low-dose decitabine treatment alone in patients with decreased donor chimerism after allo-HSCT. The investigators expect an overall response rate of 80% without serious toxicity such as grade III-IV aGVHD, ext cGVHD and lethal infection event associated with low-dose decitabine (LD-DAC) treatment. In case of donor chimerism decreasing, 5-day low-dose decitabine (5mg/m2) will given every 6 to 8 weeks until full donor chimerism is achieved (\\>98%). Fast withdraw of immuno-suppression or stop of immunosupression is not carried out in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients after allogeneic stem cell transplantation\n* decreasing of donor chimerism to less than 97%\n* providing inform consent\n\nExclusion Criteria:\n\n* patients with documented relapse disease\n* patients with documented positive MRD+ (\\>0.1% via flowcytometry or PCR)\n* patients with active infection or grade III-IV GVHD'}, 'identificationModule': {'nctId': 'NCT03663751', 'briefTitle': 'Low-dose Decitabine for the Treatment of Decreased Donor Chimerism After Allogeneic Stem Cell Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Pre-emptive Therapy With Low-dose Decitabine for Patients With Decreased Donor Chimerism After Allogeneic Stem Cell Transplantation', 'orgStudyIdInfo': {'id': 'RJ-BMT-2018-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'The peripheral and bone marrow T cell and mono nucleated cell chimerism will be closely followed-up. In case of decreasing donor chimerism, patients will receive low-dose decitabine with 5mg/m2 daily for 5 days every 6-8 weeks until the chimerism recovered to full donor type (\\>98%).', 'interventionNames': ['Drug: Decitabine']}], 'interventions': [{'name': 'Decitabine', 'type': 'DRUG', 'otherNames': ['LD-DAC'], 'description': 'low-dose decitabine: 5mg/m2 daily for 5 days', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Blood & Marrow Transplantation Center, RuiJin Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Jiong HU', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Hematology, Rui jin Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head, BMT program, Deputy director, Department of Hematology, Rui Jin Hospital', 'investigatorFullName': 'Jiong HU', 'investigatorAffiliation': 'Shanghai Jiao Tong University School of Medicine'}}}}