Safety of Tacrolimus And Methotrexate (MTX) Versus Tacrolimus And Mycophenolate Mofetil (MMF) As Graft Versus Host Disease Prophylaxis In Allogeneic Hematopoietic Cell Transplants (HCT)
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of Severe Mucositis
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.
Janelle Perkins, PharmD
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
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