A Randomized Study to Evaluate The Efficacy of Mycophenolate Mofetil Added to The Systemic Immunosuppressive Regimen First Used For Treatment of Chronic Graft-Versus-Host Disease
OBJECTIVES:
- Compare the efficacy of immunosuppressive treatment regimens with vs without
mycophenolate mofetil in patients with newly diagnosed chronic graft-vs-host disease.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled, prospective, multicenter
study. Patients are stratified according to organ involvement of chronic graft-versus-host
disease (GVHD) (single organ vs multiple organs) and transplant center. Patients are
randomized to 1 of 2 treatment arms.
All patients receive usual therapy for chronic GVHD comprising oral prednisone twice daily
and oral cyclosporine, oral tacrolimus or oral sirolimus twice daily until 2 weeks after the
first evidence of improvement of symptoms of chronic GVHD.
- Arm I: Patients receive oral mycophenolate mofetil twice daily.
- Arm II: Patients receive oral placebo twice daily. In both arms administration of the
study drug continues for 3 months after completion of prednisone and cyclosporine,
tacrolimus or sirolimus in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then every 3 months.
Patients are followed every 3 months for 3-5 years.
PROJECTED ACCRUAL: A total of 230 patients (115 per treatment arm) will be accrued for this
study within 3 years.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Cure of Chronic GVHD Without Resorting to Secondary Systemic Therapy
Withdrawal of all systemic immunosuppressive treatment after resolution of chronic GVHD, before death or onset of recurrent malignancy
2 years
No
Paul J. Martin, MD
Principal Investigator
Fred Hutchinson Cancer Research Center
United States: Food and Drug Administration
1697.00
NCT00089141
May 2004
September 2008
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
Hackensack University Medical Center Cancer Center | Hackensack, New Jersey 07601 |
UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha, Nebraska 68198-7680 |
Masonic Cancer Center at University of Minnesota | Minneapolis, Minnesota 55455 |
M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
University of Washington School of Medicine | Seattle, Washington 98195 |
Stanford Cancer Center | Stanford, California 94305-5824 |
Texas Transplant Institute | San Antonio, Texas 78229 |
Oregon Health and Science University Cancer Institute | Portland, Oregon 97239-3098 |
Baylor University Medical Center - Dallas | Dallas, Texas 75246 |