CompletedNot Applicable

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

United States89 participantsStarted 2005-09

Plain-language 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.

Who can participate

SexALL

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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

What they're measuring

Incidence of Severe Mucositis

Timeframe: 2 year

Trial details

NCT IDNCT00360685

SponsorH. Lee Moffitt Cancer Center and Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-01

Results submitted2012-03-30

View on ClinicalTrials.gov More Mucositis trials