drugset / Trial / NCT00612274
Sirolimus, Tacrolimus and Short Course Methotrexate for Prevention of Acute GVHD in Recipients of Mismatched Unrelated Donor Allogeneic Stem Cell Transplantation
NaSingle-groupOpen-labelTreatment
Summary
The primary objective of this trial is to study the safety and efficacy of a novel regimen of sirolimus, tacrolimus and methotrexate as prophylaxis against acute graft versus host disease (GVHD) in recipients of mismatched unrelated donor stem cell grafts. Methotrexate is administered in a low dose format of 5mg/m2 on days +1,3 and 6 only.
Timeline
- Start
- 2007-10
- Primary completion
- 2014-10
- Completion
- 2014-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methotrexate | Small molecule | 5 mg/m2 | Intravenous |
| Subject | Sirolimus | Small molecule | 4 mg | Oral |
| Subject | Tacrolimus | Small molecule | 0.02 mg/kg | Intravenous |