drugset / Trial / NCT01860170
Post-Transplant Bortezomib and High Dose Cyclophosphamide as Graft-Versus-Host Disease (GVHD) Prophylaxis
Non-randomizedParallel-groupOpen-labelPrevention
Summary
The purpose of this study is to determine if Bortezomib, known commercially as Velcade is safe and tolerated at different dose levels (amounts) with high dose Cyclophosphamide to be used as graft versus host disease prevention after reduced-intensity allogeneic hematopoietic stem cell transplantation.
Timeline
- Start
- 2012-04
- Primary completion
- 2016-03
- Completion
- 2018-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bortezomib | Small molecule | 0.7 mg/m2 | Intravenous |
| Comparator | Bortezomib | Small molecule | 1 mg/m2 | Intravenous |
| Comparator | Bortezomib | Small molecule | 1.3 mg/m2 | Intravenous |
| Comparator | Busulfan | Small molecule | 0.8 mg/kg | — |
| Comparator | Cyclophosphamide | Other / unclassified | 50 mg/kg | — |
| Comparator | Fludarabine | Small molecule | 30 mg/m2 | — |
| Comparator | Furosemide | Other / unclassified | — | — |
| Comparator | rATG | Unknown | 2 mg/kg | — |