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

H. Lee Moffitt Cancer Center and Research Institute

Status: Completed

Conditions: Graft-versus-host Disease; Mucositis

Treatments: Drug: TAC + MMF; Drug: Tac+MTX

Study type: Interventional

Funder types: Other

Identifiers

NCT00360685

MCC-14418

Details and patient eligibility

About

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.

Full 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.

Enrollment: 89 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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89 participants in 2 patient groups

TAC + MMF

Other group

Description:

Tacrolimus and Mycophenolate

Treatment:

Drug: TAC + MMF

TAC+MTX

Other group

Description:

Tacrolimus and Methotrexate

Treatment:

Drug: Tac+MTX