drugset / Trial / NCT00928018
Tacrolimus/Sirolimus/Methotrexate vs Tacrolimus/Methotrexate or Cyclosporine/Mycophenolate Mofetil for GVHD Prophylaxis After Reduced Intensity Allogeneic Stem Cell Transplantation for Patients With Lymphoma
Phase 3
Completed
139 enrolled
Dana-Farber Cancer Institute
Brigham and Women's Hospital · collabMassachusetts General Hospital · collabNational Cancer Institute (NCI) · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This trial is comparing whether using a drug called sirolimus for graft versus host disease (GVHD) prevention can decrease the chance of the participant's lymphoma relapsing after transplantation, compared to using a standard GVHD prevention regimen without sirolimus. Since mTOR inhibitors have anti-lymphoma activity, their use after transplantation may lead to a decreased risk of relapse and hence better transplantation outcome.
Timeline
- Start
- 2009-06
- Primary completion
- 2014-11
- Completion
- 2014-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclosporine | Peptide | 6 mg/kg | Oral |
| Comparator | Mycophenolate mofetil (MMF) | Unknown | 3 g | Oral |
| Comparator | Sirolimus | Small molecule | 4 mg | Oral |
| Comparator | Methotrexate | Small molecule | 5 mg/m2 | Intravenous |
| Comparator | Tacrolimus | Small molecule | 0.05 mg/kg | Oral |