drugset / Trial / NCT02487069
Allo-HSCT With Alternative Donor in Treatment of Hematologic Malignancy
Completed
876 enrolled
Nanfang Hospital, Southern Medical University
First Affiliated Hospital of Guangxi Medical University · collabFujian Medical University Union Hospital · collabGuangdong Provincial People's Hospital · collabGuangzhou First People's Hospital · collabGuangzhou General Hospital of Guangzhou Military Command · collabSun Yat-Sen Memorial Hospital of Sun Yat-Sen University · collabThird Affiliated Hospital, Sun Yat-Sen University · collabTongji Hospital · collabUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology · collabXiangya Hospital of Central South University · collabZhujiang Hospital · collab
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2015-06
- Primary completion
- 2020-01-31
- Completion
- 2020-02-29
Publications
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) | Protein / enzyme biologic | 7 mg/kg | — |
| Subject | ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) | Protein / enzyme biologic | 7.5 mg/kg | — |
| Subject | ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) | Protein / enzyme biologic | 10 mg/kg | — |
| Subject | Mycophenolate Mofetil | Small molecule | — | — |
| Background | Cyclosporine | Peptide | — | — |
| Background | Methotrexate | Small molecule | — | — |