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 Blood, 21 May 2009, Vol. 113, No. 21, pp. 5074-5082.
Prepublished online as a Blood First Edition Paper on March 6, 2009; DOI 10.1182/blood-2009-02-202937.

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CLINICAL TRIALS AND OBSERVATIONS

Evaluation of mycophenolate mofetil for initial treatment of chronic graft-versus-host disease

Paul J. Martin1,2, Barry E. Storer1,3, Scott D. Rowley4, Mary E. D. Flowers1,2, Stephanie J. Lee1,2, Paul A. Carpenter1,5, John R. Wingard6, Paul J. Shaughnessy7, Marcel P. DeVetten8, Madan Jagasia9, Joseph W. Fay10, Koen van Besien11, Vikas Gupta12, Carrie Kitko13, Laura J. Johnston14, Richard T. Maziarz15, Mukta Arora16, Pamala A. Jacobson16, and Daniel Weisdorf16

1 Fred Hutchinson Cancer Research Center, Seattle, WA; Departments of 2 Medicine and 3 Biostatistics, University of Washington, Seattle; 4 Hackensack University Medical Center, NJ; 5 Department of Pediatrics, University of Washington, Seattle; 6 University of Florida, Gainesville; 7 Texas Transplant Institute, San Antonio; 8 University of Nebraska, Omaha; 9 Vanderbilt University, Nashville, TN; 10 Baylor University Medical Center at Dallas, TX; 11 University of Chicago, IL; 12 Princess Margaret Hospital, Toronto, ON; 13 University of Michigan, Ann Arbor; 14 Stanford University, CA; 15 Oregon Health & Science University, Portland; and 16 University of Minnesota, Minneapolis

We conducted a double-blind, randomized multicenter trial to determine whether the addition of mycophenolate mofetil (MMF) improves the efficacy of initial systemic treatment of chronic graft-versus-host disease (GVHD). The primary endpoint was resolution of chronic GVHD and withdrawal of all systemic treatment within 2 years, without secondary treatment. Enrollment of 230 patients was planned, providing 90% power to observe a 20% difference in success rates between the 2 arms. The study was closed after 4 years because the interim estimated cumulative incidence of success for the primary endpoint was 23% among 74 patients in the MMF arm and 18% among 77 patients in the control arm, indicating a low probability of positive results for the primary endpoint after completing the study as originally planned. Analysis of secondary endpoints showed no evidence of benefit from adding MMF to the systemic regimen first used for treatment of chronic GVHD. The estimated hazard ratio of death was 1.99 (95% confidence interval, 0.9-4.3) among patients in the MMF arm compared with the control arm. MMF should not be added to the initial systemic treatment regimen for chronic GVHD. This trial was registered at www.clinicaltrials.gov as #NCT00089141 [ClinicalTrials.gov] on August 4, 2004.


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