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Tacrolimus and Mycophenolate Mofetil (MMF) in GVHD Prophylactic Regimen Compared to Tacrolimus and Methotrexate (MTX
This study is ongoing, but not recruiting participants.
Sponsored by: H. Lee Moffitt Cancer Center and Research Institute
Information provided by: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00360685
  Purpose

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.


Condition Intervention
Mucositis
Graft-Versus-Host Disease
Drug: tacrolimus (TAC)
Drug: mycophenolate mofetil (MMF)
Drug: methotrexate (MTX)

Genetics Home Reference related topics: thrombotic thrombocytopenic purpura
Drug Information available for: Methotrexate Tacrolimus Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Tacrolimus anhydrous
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title: Safety of Tacrolimus And Methotrexate (MTX) Versus Tacrolimus And Mycophenolate Mofetil (MMF) As Graft Versus Host Disease Prophylaxis In Allogeneic Hematopoietic Cell Transplants (HCT)

Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Compare the incidence of severe mucositis (CTCAE v3) in HCT patients TAC + MMF to those receiving TAC + MTX for acute graft-versus-host disease (aGVHD).

Secondary Outcome Measures:
  • Incidence of grades II-IV aGVHD and chronic GVHD (cGVHD)- (published clinical staging and grading criteria)
  • Transplant-related organ toxicity -(CTCAE v3)
  • Immune reconstitution/T cell turnover - (absolute numbers based on tests)
  • Engraftment of neutrophils and platelets - (absolute neutrophils count is >500/mm3)& (absolute platelet count is >20,000/mm3)
  • Length of hospitalization after transplant (date of transplant to the date of discharge)
  • Days of TPN, narcotic analgesic, and GVHD-related corticosteroid use (record start/stop dates)
  • Non-relapse mortality at 100 days and 1 year posttransplant
  • Overall and disease-free survival (time of transplant to the time of relapse/progression or death)

Estimated Enrollment: 95
Study Start Date: October 2005
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00360685

Locations
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Principal Investigator: Janelle Perkins, PharmD H. Lee Moffitt Cancer Center and Research Institute
Principal Investigator: Teresa Field, PhD, MD H. Lee Moffitt Cancer Center and Research Institute
  More Information

Moffiitt Cancer Center Clinical Trials Website  This link exits the ClinicalTrials.gov site

Responsible Party: H. Lee Moffitt Cancer Center & Research Institute ( Jeffrey Lancet, MD )
Study ID Numbers: MCC-14418
Study First Received: August 3, 2006
Last Updated: July 21, 2008
ClinicalTrials.gov Identifier: NCT00360685  
Health Authority: United States: Food and Drug Administration

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Tacrolimus
Methotrexate
Mycophenolate mofetil
Mucositis
Acute graft-versus-host disease (aGVHD)
Engraftment
hemolytic/uremic syndrome (HUS)
Thrombotic thrombocytopenic purpura (TTP)

Study placed in the following topic categories:
Purpura
Mouth Diseases
Mucositis
Gastrointestinal Diseases
Graft versus host disease
Mycophenolic Acid
Tacrolimus
Purpura, Thrombotic Thrombocytopenic
Purpura, Thrombocytopenic
Homologous wasting disease
Folic Acid
Digestive System Diseases
Mycophenolate mofetil
Graft vs Host Disease
Methotrexate
Stomatognathic Diseases
Gastroenteritis

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Reproductive Control Agents
Antibiotics, Antineoplastic
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009