Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-02-28 @ 10:01 PM
Study NCT ID:
NCT03423706
Status:
UNKNOWN
Last Update Posted:
2019-12-17
First Post:
2018-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Studies of New Model Haploidentical Hematopoietic Stem Cell Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-16', 'studyFirstSubmitDate': '2018-01-16', 'studyFirstSubmitQcDate': '2018-02-05', 'lastUpdatePostDateStruct': {'date': '2019-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'disease free survival at six months', 'timeFrame': 'six months', 'description': 'the disease free survival of the new model haplo-HSCT will be assessed at 6 months.'}, {'measure': 'acute graft-versus-host disease', 'timeFrame': 'three months', 'description': 'we will examine the treatment-related acute GVHD at 3 months.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['CD19-chimeric Antigen Receptor T Cells', 'Relapsed and/or Refractory Acute Lymphoblastic Leukemia', 'the Haploidentical Hematopoietic Stem Cell Transplantation']}, 'descriptionModule': {'briefSummary': 'Building a new haploid transplanted model with high-dose CTX、CD19-CART,donor CD34+ hematopoietic stem cell and Tregs,to prevent graft-versus-host disease(GVHD),reduce the infection,promote the rate of immune reconstruction，seperate graft versus leukemia（GVL）and GVHD，then to reduce the relapse rate after hematopoietic stem cell transplantation（HSCT）for relapsed and/or refractory B cell acute lymphoblastic leukemia（r/r-B-ALL）.', 'detailedDescription': 'compare the new haplo-HSCT model with the traditional haplo-HSCT in DFS、OS、RFS、CR and the degree of GVHD.etc.for the r/r B-ALL patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. the r/r B-ALL patients\n2. have the healthy allo-HSCT donor\n3. voluntary and signed the treatment protocol\n\nExclusion Criteria:\n\n1. not match the inclusion criteria\n2. important organ is dysfunction, such as heart and/or renal dysfunction,liver failure\n3. Pregnancy or breast-feeding women\n4. has virus infection,such as HIV,hepatitis virus,and can not be cleared with anti-virus treatment'}, 'identificationModule': {'nctId': 'NCT03423706', 'briefTitle': 'Clinical Studies of New Model Haploidentical Hematopoietic Stem Cell Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Harbin Medical University'}, 'officialTitle': 'Clinical Studies of New Model Haploidentical Hematopoietic Stem Cell Transplantation', 'orgStudyIdInfo': {'id': 'CART'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'new model of haplo-HSCT', 'description': 'use the new model of haplo-HSCT to treat the r/r B-ALL patients matching the inclusion criterion', 'interventionNames': ['Procedure: the new model of haplo-HSCT for r/r B-ALL']}], 'interventions': [{'name': 'the new model of haplo-HSCT for r/r B-ALL', 'type': 'PROCEDURE', 'description': 'take advantage of high-dose CTX、CD19-CART、donor CD34+HSC and Tregs to create a new model of haplo-HSCT for the patients in r/r B-ALL,to improve the quality of HSCT.', 'armGroupLabels': ['new model of haplo-HSCT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '150001', 'city': 'Harbin', 'state': 'Heilongjiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'min li li, master', 'role': 'CONTACT', 'email': 'llilimin@163.com', 'phone': '13796615495'}], 'facility': 'First affiliated hospital of Harbin medical university', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}], 'centralContacts': [{'name': 'min li li, master', 'role': 'CONTACT', 'email': 'llilimin@163.com', 'phone': '13796615495'}], 'overallOfficials': [{'name': 'jin zhou, doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'First affliliated hospital of Harbin medical university'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Harbin Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}