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


N/A
N/A
N/A
Not Enrolling
Both
Mucositis, Graft-versus-host Disease

Thank you

Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of Severe Mucositis

Outcome Description:

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.

Outcome Time Frame:

2 year

Safety Issue:

No

Principal Investigator

Janelle Perkins, PharmD

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

MCC-14418

NCT ID:

NCT00360685

Start Date:

September 2005

Completion Date:

January 2011

Related Keywords:

  • Mucositis
  • Graft-Versus-Host Disease
  • Tacrolimus
  • Methotrexate
  • Mycophenolate mofetil
  • Mucositis
  • Acute graft-versus-host disease (aGVHD)
  • Engraftment
  • hemolytic/uremic syndrome (HUS)
  • Thrombotic thrombocytopenic purpura (TTP)
  • Graft vs Host Disease
  • Mucositis

Name

Location
H. Lee Moffitt Cancer Center & Research Institute Tampa, Florida  33612