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

Not Applicable

Completed

• Conditions: Mucositis; Graft-versus-host Disease
• Interventions: Drug: TAC + MMF; Drug: Tac+MTX

• Registration Number: NCT00360685
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief 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.

Detailed Description

The randomization for this comparative trial will be stratified by conditioning regimen and, for those patients enrolled on MCC-14178, by busulfan AUC level.

All patients will receive daily doses of TAC beginning day -3 (day 0 being the day of hematopoietic stem cell transplant (HCT)) and will be given until day +60 when tapering will begin in the absence of GVHD. Provided no GVHD develops, TAC should be discontinued by day +180. Doses will be adjusted to maintain blood levels.

In addition to TAC, patients will be randomized to one of the following additional anti-GVHD medications: MTX or MMF beginning day 0 at least 2 hours after the end of the HCT. In the absence of GVHD a tapering schedule will begin on day +240 and be completed on day +360.

Study participants will be extensively monitored as inpatients and then weekly as outpatients. Some tests will be conducted at least twice weekly (blood tests, toxicity data, GVHD and physical exams) one-month post-transplant and during the tapering off periods for up to 2 years.

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2006-08-03
• Study First Submitted QC: 2006-08-03
• Study First Posted: 2006-08-07
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Results First Submitted: 2012-03-30
• Status Verified: 2013-03
• Results First Submitted QC: 2013-03-22
• Last Update Submitted: 2013-03-22
• Results First Posted: 2013-05-03
• Last Update Posted: 2013-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAC + MMF	TAC + MMF	Tacrolimus and Mycophenolate
TAC+MTX	Tac+MTX	Tacrolimus and Methotrexate

Primary Outcome Measures

Name	Time	Method
Incidence of Severe Mucositis	2 year	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of Acute Graft-vs-host Disease (aGVHD)	100 days post transplant	incidence of aGVHD (grades 2 - 4) 100 days post allogeneic hematopoietic cell transplantation
Overall Survival	1 year	number of participants alive at one year

Trial Locations

Locations (1)

H. Lee Moffitt Cancer Center & Research Institute; 🇺🇸 Tampa, Florida, United States