Allo-HSCT With Alternative Donor in Treatment of Hematologic Malignancy
NCT ID: NCT02487069
Last Updated: 2020-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
876 participants
INTERVENTIONAL
2015-06-30
2020-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MSD group
The patients will received HSCT from MSD.
HSCT from MSD
HSCT from MSD is the first choice for the patients who have HLA-matched sibling donors.
Cyclosporin A
CsA is used in all the patients for GVHD prophylaxis.
Methotrexate
MTX is used in all the patients for GVHD prophylaxis.
Mycophenolate mofetil
MMF is used in the patients receiving HSCT from MSD and HRD for GVHD prophylaxis.
MUD group
The patients will received HSCT from MUD.
HSCT from MUD
HSCT from MUD is the second choice for the patients who don't have HLA-matched sibling donors but have HLA-matched unrelated donors.
Cyclosporin A
CsA is used in all the patients for GVHD prophylaxis.
Methotrexate
MTX is used in all the patients for GVHD prophylaxis.
Antithymocyte globulin
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.
HRD group
The patients will received HSCT from HRD.
HSCT from HRD
HSCT from HRD is the choice for the patients who have neither HLA-matched sibling donors nor HLA-matched unrelated donors.
Cyclosporin A
CsA is used in all the patients for GVHD prophylaxis.
Methotrexate
MTX is used in all the patients for GVHD prophylaxis.
Antithymocyte globulin
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.
Mycophenolate mofetil
MMF is used in the patients receiving HSCT from MSD and HRD for GVHD prophylaxis.
Interventions
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HSCT from MSD
HSCT from MSD is the first choice for the patients who have HLA-matched sibling donors.
HSCT from MUD
HSCT from MUD is the second choice for the patients who don't have HLA-matched sibling donors but have HLA-matched unrelated donors.
HSCT from HRD
HSCT from HRD is the choice for the patients who have neither HLA-matched sibling donors nor HLA-matched unrelated donors.
Cyclosporin A
CsA is used in all the patients for GVHD prophylaxis.
Methotrexate
MTX is used in all the patients for GVHD prophylaxis.
Antithymocyte globulin
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.
Mycophenolate mofetil
MMF is used in the patients receiving HSCT from MSD and HRD for GVHD prophylaxis.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Receiving allo-HSCT
Exclusion Criteria
* hepatic abnormalities (bilirubin ≥ 3 mg/dL, aminotransferase\> 2 times the upper limit of normal)
* renal dysfunction (creatinine clearance rate \< 30 mL/min)
* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (investigators' decision)
18 Years
60 Years
ALL
No
Sponsors
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Guangdong Provincial People's Hospital
OTHER
Third Affiliated Hospital, Sun Yat-Sen University
OTHER
Guangzhou General Hospital of Guangzhou Military Command
OTHER
Guangzhou First People's Hospital
OTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Zhujiang Hospital
OTHER
Tongji Hospital
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Fujian Medical University Union Hospital
OTHER
First Affiliated Hospital of Guangxi Medical University
OTHER
Xiangya Hospital of Central South University
OTHER
Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Qifa Liu
Professor
Principal Investigators
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Qifa Liu
Role: PRINCIPAL_INVESTIGATOR
Nanfang Hospital, Southern Medical University
Locations
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Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Countries
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References
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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.
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.
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.
Other Identifiers
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Alternative Donor HSCT-2015
Identifier Type: -
Identifier Source: org_study_id
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