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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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2019-02-01

Study results available
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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.

Conditions

Interventions

DRUG

Sirolimus

Taken orally for at least 12 months

DRUG

Methotrexate

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

DRUG

Tacrolimus

Taken orally or given intravenously for at least 6 months

DRUG

Cyclosporine

Taken orally or given intravenously for at least 6 months

DRUG

MMF

Taken orally for about 2 months

Sponsors & Collaborators

  • Brigham and Women's Hospital

    collaborator OTHER

  • Massachusetts General Hospital

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • Dana-Farber Cancer Institute

    lead OTHER

Principal Investigators

  • Philippe Armand, MD, PhD · Dana-Farber Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
72 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00928018 on ClinicalTrials.gov