CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 89 enrolled
Drug / intervention
Tac+MTX +1 moredrug
Likely dose
Tac+MTX 0.03mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00360685
NCT00360685N/ACompleted
CompareCT.gov

Safety of Tacrolimus And Methotrexate (MTX) Versus Tacrolimus And Mycophenolate Mofetil (MMF) As Graft Versus Host Disease Prophylaxis In Allogeneic Hematopoietic Cell Transplants (HCT)

H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Aug 7, 2006·Updated May 3, 2013

In Brief

A clinical study evaluating Tac+MTX and TAC + MMF for Mucositis and Graft-versus-host Disease. Completed, enrolled 89 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMucositis, Graft-versus-host Disease
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 7, 2006
Enrollment StartSep 1, 2005
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 19.9 years ago

Interventions

Tac+MTXdrug

Tacrolimus- 0.03mg/kg/24h IV beginning day-3 Methotrexate- 15mg/m2 IV day +1 then 10mg/m2 IV on days 3, 6, 11 post transplant.

TAC + MMFdrug

Tacrolimus- 0.03 mg/kg/24h as a continuous IV infusion, beginning day -3. Mycophenolate Mofetil- 30 mg/kg/day IV in 2 divided doses (q12 hours) beginning day 0 at least 2 hours after the end of the hematopoietic stem cell transplant