drugset / Trial / NCT00796562
Safety Study of Bone Marrow Transplant Using Mismatched Tissue Followed by Chemotherapy
Phase 2
Completed
107 enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Center for Research Resources (NCRR) · collabOtsuka Pharmaceutical Co., Ltd. · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to see if giving high dose chemotherapy and total body irradiation before and repeating high dose chemotherapy after a bone marrow transplant could reduce the incidence of graft rejection and disease for patients with blood cancers
Timeline
- Start
- 2008-12
- Primary completion
- 2014-06
- Completion
- 2016-11
Publications
- Background Fine J.P. and Gray, R.J. (1999), A proportional hazards model for the subdistribution of a competing risk, Journal of the American Statistical Association, 94:496-509.
- Symons HJ, Zahurak M, Cao Y, Chen A, Cooke K, Gamper C, Klein O, Llosa N, Zambidis ET, Ambinder R, Bolanos-Meade J, Borrello I, Brodsky R, DeZern A, Gojo I, Showel M, Swinnen L, Smith BD, Luznik L, Jones RJ, Fuchs EJ. Myeloablative haploidentical BMT with posttransplant cyclophosphamide for hematologic malignancies in children and adults. Blood Adv. 2020 Aug 25;4(16):3913-3925. doi: 10.1182/bloodadvances.2020001648.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Busulfan | Small molecule | 0.8 mg/kg | Oral |
| Subject | Busulfan | Small molecule | 1 mg/kg | Oral |
| Subject | Cyclophosphamide | Other / unclassified | 50 mg/kg | Intravenous |