Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-03-03 @ 6:29 AM
Study NCT ID:
NCT02487069
Status:
COMPLETED
Last Update Posted:
2020-03-05
First Post:
2015-06-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Allo-HSCT With Alternative Donor in Treatment of Hematologic Malignancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D000961', 'term': 'Antilymphocyte Serum'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}], 'ancestors': [{'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007106', 'term': 'Immune Sera'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 876}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2020-02-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-03', 'studyFirstSubmitDate': '2015-06-14', 'studyFirstSubmitQcDate': '2015-06-27', 'lastUpdatePostDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '3 year', 'description': 'The primary endpoint is overall survival within 3 years after HSCT.'}], 'secondaryOutcomes': [{'measure': 'Disease-free survival', 'timeFrame': '3 year'}, {'measure': 'Incidence of transplantation-related mortality', 'timeFrame': '3 year'}, {'measure': 'Incidence of graft-versus-host disease', 'timeFrame': '3 year', 'description': 'Graft-versus-host disease include acute and chronic Graft-versus-host disease'}, {'measure': 'Incidence of infection', 'timeFrame': '3 year', 'description': 'Infection includes bacterial, fungal and viral infections.'}, {'measure': 'hematopoietic reconstruction', 'timeFrame': '1 year', 'description': 'Hematopoietic reconstruction includes the time of neutrophil and platelet reconstruction.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute Leukemia', 'Chronic Myeloid Leukemia', 'Myelodysplastic Syndrome']}, 'referencesModule': {'references': [{'pmid': '25214441', 'type': 'BACKGROUND', 'citation': 'Luo Y, Xiao H, Lai X, Shi J, Tan Y, He J, Xie W, Zheng W, Zhu Y, Ye X, Yu X, Cai Z, Lin M, Huang H. T-cell-replete haploidentical HSCT with low-dose anti-T-lymphocyte globulin compared with matched sibling HSCT and unrelated HSCT. Blood. 2014 Oct 23;124(17):2735-43. doi: 10.1182/blood-2014-04-571570. Epub 2014 Sep 11.'}, {'pmid': '16380454', 'type': 'BACKGROUND', 'citation': 'Lu DP, Dong L, Wu T, Huang XJ, Zhang MJ, Han W, Chen H, Liu DH, Gao ZY, Chen YH, Xu LP, Zhang YC, Ren HY, Li D, Liu KY. Conditioning including antithymocyte globulin followed by unmanipulated HLA-mismatched/haploidentical blood and marrow transplantation can achieve comparable outcomes with HLA-identical sibling transplantation. Blood. 2006 Apr 15;107(8):3065-73. doi: 10.1182/blood-2005-05-2146. Epub 2005 Dec 27.'}, {'pmid': '37335960', 'type': 'DERIVED', 'citation': 'Ling Y, Xuan L, Xu N, Huang F, Fan Z, Guo Z, Xu X, Liu H, Lin R, Yu S, Zhang H, Jin H, Wu M, Liu C, Liang X, Ou R, Zhang Y, Liu X, Qu H, Zhai X, Sun J, Zhao Y, Liu Q. Busulfan Plus Fludarabine Compared With Busulfan Plus Cyclophosphamide for AML Undergoing HLA-Haploidentical Hematopoietic Cell Transplantation: A Multicenter Randomized Phase III Trial. J Clin Oncol. 2023 Oct 10;41(29):4632-4642. doi: 10.1200/JCO.23.00101. Epub 2023 Jun 19.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy of allogeneic hematopoietic stem cell transplantation (allo-HSCT) from matched sibling donor (MSD),matched unrelated donor (MUD) and haploidentical related donors(HRD) in the treatment of hematologic malignancy.', 'detailedDescription': 'Currently, allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains the only curative therapy for a majority of malignant hematologic diseases, especially acute leukemia. HSCT from MSD offers the best results for these diseases, but lack of this donor resource has restricted its wide application. HSCT from MUD provides another option, but MUDs still cannot satisfy all patients due to unsuccessful donor searches. Almost all patients have an available related donor with whom they share a single HLA haplotype (ie, haploidentical related donor), and it owns the advantage of immediate availability, especially for those who urgently need transplantation.The results of transplantation from HRD have improved significantly over the past few years. However, the results from such haploidentical transplantation have not formally been compared with those of transplantation in patients contemporaneously using MSDs and MUDs for hematologic malignancy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of primary disease is acute leukemia/MDS/CML\n* Receiving allo-HSCT\n\nExclusion Criteria:\n\n* cardiac dysfunction (particularly congestive heart failure)\n* hepatic abnormalities (bilirubin ≥ 3 mg/dL, aminotransferase\\> 2 times the upper limit of normal)\n* renal dysfunction (creatinine clearance rate \\< 30 mL/min)\n* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)\n* Patients with any conditions not suitable for the trial (investigators' decision)"}, 'identificationModule': {'nctId': 'NCT02487069', 'briefTitle': 'Allo-HSCT With Alternative Donor in Treatment of Hematologic Malignancy', 'organization': {'class': 'OTHER', 'fullName': 'Nanfang Hospital, Southern Medical University'}, 'officialTitle': 'Allogeneic Stem Cell Transplantation With Alternative Donor in Treatment of Hematologic Malignancy', 'orgStudyIdInfo': {'id': 'Alternative Donor HSCT-2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MSD group', 'description': 'The patients will received HSCT from MSD.', 'interventionNames': ['Procedure: HSCT from MSD', 'Drug: Cyclosporin A', 'Drug: Methotrexate', 'Drug: Mycophenolate mofetil']}, {'type': 'EXPERIMENTAL', 'label': 'MUD group', 'description': 'The patients will received HSCT from MUD.', 'interventionNames': ['Procedure: HSCT from MUD', 'Drug: Cyclosporin A', 'Drug: Methotrexate', 'Drug: Antithymocyte globulin']}, {'type': 'EXPERIMENTAL', 'label': 'HRD group', 'description': 'The patients will received HSCT from HRD.', 'interventionNames': ['Procedure: HSCT from HRD', 'Drug: Cyclosporin A', 'Drug: Methotrexate', 'Drug: Antithymocyte globulin', 'Drug: Mycophenolate mofetil']}], 'interventions': [{'name': 'HSCT from MSD', 'type': 'PROCEDURE', 'description': 'HSCT from MSD is the first choice for the patients who have HLA-matched sibling donors.', 'armGroupLabels': ['MSD group']}, {'name': 'HSCT from MUD', 'type': 'PROCEDURE', 'description': "HSCT from MUD is the second choice for the patients who don't have HLA-matched sibling donors but have HLA-matched unrelated donors.", 'armGroupLabels': ['MUD group']}, {'name': 'HSCT from HRD', 'type': 'PROCEDURE', 'description': 'HSCT from HRD is the choice for the patients who have neither HLA-matched sibling donors nor HLA-matched unrelated donors.', 'armGroupLabels': ['HRD group']}, {'name': 'Cyclosporin A', 'type': 'DRUG', 'otherNames': ['CsA'], 'description': 'CsA is used in all the patients for GVHD prophylaxis.', 'armGroupLabels': ['HRD group', 'MSD group', 'MUD group']}, {'name': 'Methotrexate', 'type': 'DRUG', 'otherNames': ['MTX'], 'description': 'MTX is used in all the patients for GVHD prophylaxis.', 'armGroupLabels': ['HRD group', 'MSD group', 'MUD group']}, {'name': 'Antithymocyte globulin', 'type': 'DRUG', 'otherNames': ['ATG'], 'description': 'ATG is used in the patients receiving HSCT from MUD and HRD for GVHD prophylaxis.In MUD group,total ATG doses is 7 mg/kg;In HRD group,total ATG doses is 7.5 or 10 mg/kg.', 'armGroupLabels': ['HRD group', 'MUD group']}, {'name': 'Mycophenolate mofetil', 'type': 'DRUG', 'otherNames': ['MMF'], 'description': 'MMF is used in the patients receiving HSCT from MSD and HRD for GVHD prophylaxis.', 'armGroupLabels': ['HRD group', 'MSD group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Department of Hematology,Nanfang Hospital, Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Qifa Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanfang Hospital, Southern Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'Third Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'Guangzhou General Hospital of Guangzhou Military Command', 'class': 'OTHER'}, {'name': "Guangzhou First People's Hospital", 'class': 'OTHER'}, {'name': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'Zhujiang Hospital', 'class': 'OTHER'}, {'name': 'Tongji Hospital', 'class': 'OTHER'}, {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, {'name': 'Fujian Medical University Union Hospital', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Guangxi Medical University', 'class': 'OTHER'}, {'name': 'Xiangya Hospital of Central South University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Qifa Liu', 'investigatorAffiliation': 'Nanfang Hospital, Southern Medical University'}}}}