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

NCT00928018

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

EvaluationDrugModalityDoseRoute
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