Overview

Tacrolimus and Mycophenolate Mofetil (MMF) in GVHD Prophylactic Regimen Compared to Tacrolimus and Methotrexate (MTX

Status:
Completed

Trial end date:
2011-01-01

Target enrollment:
0

Participant gender:
All

Summary

A comparative trial where all patients will receive daily doses of tacrolimus (TAC) until day +60 when tapering will begin, in the absence of graft-versus-host disease (GVHD), and discontinued by day +180. In addition patients will be randomized to methotrexate (MTX) or mycophenolate mofetil (MMF) and again, in the absence of GVHD, a tapering schedule will begin on day +240 and be completed on day +360. Doses will be adjusted to maintain blood levels.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Treatments:

Methotrexate
Mycophenolate mofetil
Mycophenolic Acid
Tacrolimus

Criteria

Inclusion Criteria:

- Patient must be going through a T cell-replete allogeneic transplant

Exclusion Criteria:

- A contraindication to the use of tacrolimus, mycophenolate, or methotrexate