CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 139 enrolled
Drug / intervention
Sirolimus +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00928018
NCT00928018Phase 3Completed

A Phase III Multicenter, Randomized Trial Comparing Tacrolimus/Sirolimus/Methotrexate Versus Tacrolimus/Methotrexate or Cyclosporine/Mycophenolate Mofetil for GVHD Prophylaxis After Reduced Intensity Allogeneic Stem Cell Transplantation for Patients With Lymphoma

Dana-Farber Cancer Institute·interventional·Posted Jun 25, 2009·Updated Feb 1, 2019

In Brief

A Phase 3 clinical trial evaluating Sirolimus, Methotrexate, and 3 other interventions for Non-hodgkin Lymphoma and Hodgkin Lymphoma. Completed, enrolled 139 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 25, 2009
Enrollment StartJun 1, 2009
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 17.0 years ago

Interventions

Sirolimusdrug

Taken orally for at least 12 months

Methotrexatedrug

Given intravenously on the first, third and sixth day after transplant

Tacrolimusdrug

Taken orally or given intravenously for at least 6 months

Cyclosporinedrug

Taken orally or given intravenously for at least 6 months

MMFdrug

Taken orally for about 2 months