Abstract:
: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 on August 4, 2004.
journal_name
Bloodjournal_title
Bloodauthors
Martin PJ,Storer BE,Rowley SD,Flowers ME,Lee SJ,Carpenter PA,Wingard JR,Shaughnessy PJ,DeVetten MP,Jagasia M,Fay JW,van Besien K,Gupta V,Kitko C,Johnston LJ,Maziarz RT,Arora M,Jacobson PA,Weisdorf Ddoi
10.1182/blood-2009-02-202937subject
Has Abstractpub_date
2009-05-21 00:00:00pages
5074-82issue
21eissn
0006-4971issn
1528-0020pii
blood-2009-02-202937journal_volume
113pub_type
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