N/A Completed N=89 Randomized Treatment

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

Mucositis · graft-versus-host disease

Source: ClinicalTrials.gov NCT00360685 ↗

Enrolled (actual)

Serious AEs

49.4%

Results posted

May 2013

Primary outcomePrimary: Incidence of Severe Mucositis — 25; 14 participants — p=0.06

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Severe Mucositis	25; 14	0.06
SECONDARY Incidence of Acute Graft-vs-host Disease (aGVHD)	45; 33	0.8
SECONDARY Overall Survival	28; 27	0.58

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00360685). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.