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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00360685
First received: August 3, 2006
Last updated: March 22, 2013
Last verified: March 2013
  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: Tac+MTX
Drug: TAC + MMF

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Incidence of Severe Mucositis [ Time Frame: 2 year ] [ Designated as safety issue: No ]
    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:
  • Incidence of Acute Graft-vs-host Disease (aGVHD) [ Time Frame: 100 days post transplant ] [ Designated as safety issue: No ]
    incidence of aGVHD (grades 2 - 4) 100 days post allogeneic hematopoietic cell transplantation

  • Overall Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    number of participants alive at one year


Enrollment: 89
Study Start Date: September 2005
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
TAC + MMF
Tacrolimus and Mycophenolate
Drug: TAC + MMF
Tacrolimus- 0.03 mg/kg/24h as a continuous IV infusion, beginning day -3. Mycophenolate Mofetil- 30 mg/kg/day IV in 2 divided doses (q12 hours) beginning day 0 at least 2 hours after the end of the hematopoietic stem cell transplant
Other Names:
  • Tacrolimus, Prograf(R)
  • Mycophenolate mofetil, CellCept(R)
TAC+MTX
Tacrolimus and Methotrexate
Drug: Tac+MTX
Tacrolimus- 0.03mg/kg/24h IV beginning day-3 Methotrexate- 15mg/m2 IV day +1 then 10mg/m2 IV on days 3, 6, 11 post transplant.
Other Names:
  • Tacrolimus, Prograf(R)
  • Methotrexate,

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
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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

Additional Information:
Publications:
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00360685     History of Changes
Other Study ID Numbers: MCC-14418
Study First Received: August 3, 2006
Results First Received: March 30, 2012
Last Updated: March 22, 2013
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)

Additional relevant MeSH terms:
Graft vs Host Disease
Mucositis
Immune System Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Methotrexate
Mycophenolic Acid
Mycophenolate mofetil
Tacrolimus
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on October 16, 2014