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

Completed · Not applicable

Conditions studied: Mucositis, Graft-versus-host Disease

In brief

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.

Key facts

Study ID

NCT00360685

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

89

Starts

2005-09-01

Expected to finish

2011-01-01

Last updated by the study team

2013-05-03

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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