Allo-HSCT With Alternative Donor in Treatment of Hematologic Malignancy
Allogeneic Stem Cell Transplantation With Alternative Donor in Treatment of Hematologic Malignancy
1 other identifier
interventional
876
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 14, 2015
CompletedFirst Posted
Study publicly available on registry
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 29, 2020
CompletedMarch 5, 2020
March 1, 2019
4.7 years
June 14, 2015
March 3, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival
The primary endpoint is overall survival within 3 years after HSCT.
3 year
Secondary Outcomes (5)
Disease-free survival
3 year
Incidence of transplantation-related mortality
3 year
Incidence of graft-versus-host disease
3 year
Incidence of infection
3 year
hematopoietic reconstruction
1 year
Study Arms (3)
MSD group
EXPERIMENTALThe patients will received HSCT from MSD.
MUD group
EXPERIMENTALThe patients will received HSCT from MUD.
HRD group
EXPERIMENTALThe patients will received HSCT from HRD.
Interventions
HSCT from MSD is the first choice for the patients who have HLA-matched sibling donors.
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 is the choice for the patients who have neither HLA-matched sibling donors nor HLA-matched unrelated donors.
CsA is used in all the patients for GVHD prophylaxis.
MTX is used in all the patients for GVHD prophylaxis.
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.
MMF is used in the patients receiving HSCT from MSD and HRD for GVHD prophylaxis.
Eligibility Criteria
You may qualify if:
- Diagnosis of primary disease is acute leukemia/MDS/CML
- Receiving allo-HSCT
You may not qualify if:
- cardiac dysfunction (particularly congestive heart failure)
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nanfang Hospital, Southern Medical Universitylead
- Guangdong Provincial People's Hospitalcollaborator
- Third Affiliated Hospital, Sun Yat-Sen Universitycollaborator
- Guangzhou General Hospital of Guangzhou Military Commandcollaborator
- Guangzhou First People's Hospitalcollaborator
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen Universitycollaborator
- Zhujiang Hospitalcollaborator
- Tongji Hospitalcollaborator
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technologycollaborator
- Fujian Medical University Union Hospitalcollaborator
- First Affiliated Hospital of Guangxi Medical Universitycollaborator
- Xiangya Hospital of Central South Universitycollaborator
Study Sites (1)
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
Related Publications (3)
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: 25214441BACKGROUNDLu 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: 16380454BACKGROUNDLing 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.
PMID: 37335960DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qifa Liu
Nanfang Hospital, Southern Medical University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 14, 2015
First Posted
July 1, 2015
Study Start
June 1, 2015
Primary Completion
January 31, 2020
Study Completion
February 29, 2020
Last Updated
March 5, 2020
Record last verified: 2019-03