drugset / Trial / NCT02342145
Efficacy of Basiliximab in the Prevention of Acute Graft-versus-host Disease in Unrelated Allogeneic Hematopoietic Stem Cell Transplantation Therapy for Thalassemia Major
Phase 4
Completed
205 enrolled
Zhongming Zhang
Guangxi Key Laboratory of Thalassemia Research · collabHainan General Hospital · collabLiuzhou Workers' Hospital · collabMcMaster University · collabNHC Key Laboratory of Thalassemia Medicine · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
The purpose of this study is to evaluate the basiliximab for prevention of graft-versus-host disease in unrelated allo-genetic hematopoietic stem cell transplantation for thalassemia major. The objective was to evaluate the effect and safety of basiliximab for acute graft-versus-host disease.
Timeline
- Start
- 2015-04
- Primary completion
- 2022-08-20
- Completion
- 2022-08-20
Publications
- Background Smiers FJ, Krishnamurti L, Lucarelli G. Hematopoietic stem cell transplantation for hemoglobinopathies: current practice and emerging trends. Pediatr Clin North Am. 2010 Feb;57(1):181-205. doi: 10.1016/j.pcl.2010.01.003.
- Background Wang HX, Yan HM, Wang ZD, Xue M, Liu J, Guo ZK. Haploidentical hematopoietic stem cell transplantation in hematologic malignancies with G-CSF mobilized bone marrow plus peripheral blood stem cells grafts without T cell depletion: a single center report of 29 cases. Leuk Lymphoma. 2012 Apr;53(4):654-9. doi: 10.3109/10428194.2011.624225. Epub 2011 Dec 5.
- Background Hu LD, Chen H, Jiang M, Li BT, Yu ZY, Li YH. [The role of CD25 antibody in unrelated hematopoietic stem cell transplantation]. Zhonghua Nei Ke Za Zhi. 2005 Nov;44(11):848-50. Chinese.
- Results Feng Z, Sun E, Lan H, Zhang C, Li Q, Zhu W. Unrelated donor bone marrow transplantation for beta-thalassemia major: an experience from China. Bone Marrow Transplant. 2006 Jan;37(2):171-4. doi: 10.1038/sj.bmt.1705193.
- Results Hongeng S, Pakakasama S, Chuansumrit A, Sirachainan N, Kitpoka P, Udomsubpayakul U, Ungkanont A, Jootar S. Outcomes of transplantation with related- and unrelated-donor stem cells in children with severe thalassemia. Biol Blood Marrow Transplant. 2006 Jun;12(6):683-7. doi: 10.1016/j.bbmt.2006.02.008.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Basiliximab | Monoclonal antibody | 10 mg | — |
| Subject | Basiliximab | Monoclonal antibody | 20 mg | — |
| Background | Methotrexate | Small molecule | 10 mg/m2 | Intravenous |
| Background | Mycophenolate Mofetil | Small molecule | 0.25 g | — |
| Background | Tacrolimus | Small molecule | 0.1 mg/kg | Intravenous |