Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2025-12-27 @ 2:28 AM
Study NCT ID:
NCT05103995
Status:
COMPLETED
Last Update Posted:
2021-11-02
First Post:
2021-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Donor-recipient ABO Matching on Haploidentical Stem Cell Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 510}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-22', 'studyFirstSubmitDate': '2021-10-10', 'studyFirstSubmitQcDate': '2021-10-22', 'lastUpdatePostDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '5-year Overall Survival', 'timeFrame': '5 year', 'description': '5-year Overall Survival'}], 'secondaryOutcomes': [{'measure': '5-year Non-relapse mortality', 'timeFrame': '5 year', 'description': '5-year non-relapse mortality'}, {'measure': '5-year cumulative incidence of chronic graft versus host disease', 'timeFrame': '5 year', 'description': '5-year cumulative incidence of chronic graft versus host disease'}, {'measure': '28-day cumulative incidence of neutrophils engraftment', 'timeFrame': '28 day', 'description': 'numbers of participants achieved neutrophils engraftment at 28 days post transplantation'}, {'measure': '28-day cumulative incidence of platelets engraftment', 'timeFrame': '28 day', 'description': 'numbers of participants achieved platelets engraftment at 28 days post transplantation'}, {'measure': '365-day blood transfusion requirements', 'timeFrame': '365 day', 'description': 'numbers of blood products transfusion within 365-day after transplantation'}, {'measure': 'cumulative incidence of blood transfusion independence within 60 days after transplantation', 'timeFrame': '60 day', 'description': 'numbers of participants achieved blood transfusion independence within 60 days after transplantation'}, {'measure': 'the 5-year cumulative incidence of poor graft function the incidence of poor graft function', 'timeFrame': '5 year', 'description': 'numbers of participants occurred poor graft function 5 years post transplantation'}, {'measure': 'the 5-year cumulative incidence of graft failure', 'timeFrame': '5-year', 'description': 'numbers of participants occurred graft failure 5 years post transplantation'}, {'measure': '100-day cumulative incidence of acute graft versus host disease', 'timeFrame': '100-day', 'description': '100-day cumulative incidence of acute graft versus host disease'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['haploidentical stem cell transplantation', 'hematological malignancies', 'ABO incompatibility'], 'conditions': ['Hematological Malignancies', 'Haploidentical Stem Cell Transplantation']}, 'descriptionModule': {'briefSummary': 'the impact of donor-recipient ABO matching on outcome of peripheral blood stem cell haploidentical hematopoietic stem cell transplantation', 'detailedDescription': 'The impact of donor-recipient ABO compatibility on transplant outcomes had been evaluated in different transplant settings, but had shown different results. The investigators set out to investigate the impact of ABO incompatibility on post-transplant outcomes, engraftment kinetics and blood product requirements, transfusion independence, the incidence of poor graft function (PGF) in anti-T-lymphocyte globulin (ATG) based haplo-SCT with PBSC grafts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with malignant hematological diseases plan to receive allogeneic peripheral blood stem cell transplantation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. The subjects or their legal representatives signed the informed consent before the clinical study. 2. Subjects aged 15-70 years. 3. Patients with malignant hematological diseases plan to receive allogeneic peripheral blood stem cell transplantation 4. Patients have no suitable HLA identical sibling donor 5.Patients with malignant hematological diseases plan to receive HLA haploidentical stem cell transplantation 6. Subjects with ECoG score of 0-2.\n\nExclusion Criteria:\n\n1.Patients have suitable HLA identical sibling donor 2. Patients with severe liver and kidney function (alanine aminotransferase \\> 2.5 times of the upper normal limit, serum creatinine \\> 1.5 times of the upper normal limit), cardiopulmonary dysfunction (cardiac function NYHA III / IV, cardiac ejection fraction \\< 50%, severe obstructive or restrictive ventilation dysfunction); 3. Patients with active infection; 4. patients diagnosed with aplastic anemia before transplantation or died within 2 months after transplantation; 5. Subjects with ECoG score \\> 2; 6. Patients with secondary tumor; 7. Patients who cannot independently choose to enter or exit clinical trials due to serious central nervous system disease or mental disease.'}, 'identificationModule': {'nctId': 'NCT05103995', 'briefTitle': 'Impact of Donor-recipient ABO Matching on Haploidentical Stem Cell Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Zhejiang University'}, 'officialTitle': "Impact of Donor-recipient ABO Matching on Patients' Outcome After Peripheral Blood Stem Cell Haploidentical Stem Cell Transplantation", 'orgStudyIdInfo': {'id': 'ZJU-haplo-abo'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ABO matched', 'description': 'Donor-recipient ABO matched', 'interventionNames': ['Other: no intervention']}, {'label': 'Minor incompatibility', 'description': 'Donor-recipient minor incompatibility', 'interventionNames': ['Other: no intervention']}, {'label': 'Major incompatibility', 'description': 'Donor-recipient major incompatibility', 'interventionNames': ['Other: no intervention']}, {'label': 'Bidirectional incompatibility', 'description': 'Donor-recipient bidirectional incompatibility', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'no intervention, just observation', 'armGroupLabels': ['ABO matched', 'Bidirectional incompatibility', 'Major incompatibility', 'Minor incompatibility']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The first Affiliated Hospital of Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Jinhua', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Affiliated Jinhua hospital of Zhejiang University', 'geoPoint': {'lat': 29.10678, 'lon': 119.64421}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Affiliated Jinhua Hospital of Zhejiang University', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yi Luo', 'investigatorAffiliation': 'First Affiliated Hospital of Zhejiang University'}}}}