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NCT00360685 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Completed
Registry status
NA
Development phase
89
Enrollment target

NCT00360685: Completed NA study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

NCT00360685 is a NA study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 89 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00360685, a NA study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

COMPLETED
Registry status
NA
Development phase
89 participants
Enrollment target

Study 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.

Primary Outcome

Mucositis was assessed prospectively daily while the patient was hospitalized and graded retrospectively based on nurse and clinician assessments according to the clinical criteria set forth in the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 3.0). Severe mucositis as defined as grade 3 or grade 4.

Interventions

  • DRUG Tac+MTX
  • DRUG TAC + MMF

Trial Details

FieldValue
Enrollment Target 89 participants
Start Date 2005-09
Est. Completion 2011-01
Phase NA

What the finished NCT00360685 record still lists

NCT00360685 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 2 interventions - of which Tac+MTX is the first listed.

NCT00360685 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00360685 about?

NCT00360685 is a clinical study titled "Tacrolimus and Mycophenolate Mofetil (MMF) in GVHD Prophylactic Regimen Compared to Tacrolimus and Methotrexate (MTX". 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) a...

What is the current status of trial NCT00360685?

This trial is currently completed. It is a NA study. The enrollment target is 89 participants. The study started on 2005-09. Estimated completion is 2011-01.

What interventions are being tested in trial NCT00360685?

The interventions under investigation include: Tac+MTX (DRUG), TAC + MMF (DRUG).

Who is sponsoring clinical trial NCT00360685?

This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00360685's enrollment target sits among peer trials

89 972nd of 2000 higher than 1,029 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00360685, the US trial registry maintained by the National Library of Medicine. NCT00360685 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.