EurekaMag.com logo
+ Site Statistics
References:
53,869,633
Abstracts:
29,686,251
+ Search Articles
+ Subscribe to Site Feeds
EurekaMag Most Shared ContentMost Shared
EurekaMag PDF Full Text ContentPDF Full Text
+ PDF Full Text
Request PDF Full TextRequest PDF Full Text
+ Follow Us
Follow on FacebookFollow on Facebook
Follow on TwitterFollow on Twitter
Follow on LinkedInFollow on LinkedIn

+ Translate

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



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



Blood 113(21): 5074-5082



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.

(PDF emailed within 0-6 h: $19.90)

Accession: 053076131

Download citation: RISBibTeXText

PMID: 19270260

DOI: 10.1182/blood-2009-02-202937



Related references

Mycophenolate mofetil for the treatment of chronic graft versus host disease of the liver. Blood 94(10 SUPPL 1 PART 1): 159a, Nov 15, 1999

Efficacy of mycophenolate mofetil in the treatment of chronic graft-versus-host disease. Biology of Blood and Marrow Transplantation 11(4): 307-313, 2005

The use mycophenolate mofetil in the treatment of refractory chronic graft versus host disease. Blood 92(10 SUPPL 1 PART 1-2): 346B, Nov 15, 1998

Treatment of acute and chronic graft versus host disease with mycophenolate mofetil. Blood 94(10 SUPPL 1 PART 2): 368b, Nov 15, 1999

Mycophenolate mofetil for the treatment of acute and chronic steroid-refractory graft-versus-host disease. Annals of Hematology 84(10): 681-685, 2005

Mycophenolate mofetil is effective and well tolerated in the treatment of refractory acute and chronic graft-versus-host disease. International Journal of Hematology 83(1): 80-85, 2006

Mycophenolate mofetil as salvage treatment for steroid-refractory chronic graft versus-host disease in children. Blood 98(11 Part 1): 398a, November 16, 2001

A high risk of life-threatening infectious complications in mycophenolate mofetil treatment for acute or chronic graft-versus-host disease. International Journal of Hematology 91(3): 464-470, 2010

Mycophenolate mofetil (MMF) for refractory chronic graft versus host disease (cGvHD). Haematologica 88(8): Elt28; Author Reply Elt29-Elt28; Author Reply Elt29, 2003

Response to mycophenolate mofetil therapy for refractory chronic graft-versus-host disease. Haematologica 88(7): 837-839, July, 2003

Salvage therapy with mycophenolate mofetil and FK-506 for refractory chronic graft-versus-host disease. Blood 92(10 SUPPL 1 PART 1-2): 457A, Nov 15, 1998

Salvage therapy for refractory chronic graft-versus-host disease with mycophenolate mofetil and tacrolimus. Bone Marrow Transplantation 24(5): 517-520, Sept 1, 1999

Treatment of severe bone marrow graft versus host disease with mycophenolate mofetil. Journal of Allergy & Clinical Immunology 107(2): S297, February, 2001

Mycophenolate mofetil as rescue therapy for high-risk steroid-refractory chronic graft versus-host-disease. Pediatric Research 53(4 Part 2): 275A, April, 2003

Conversion from Mycophenolate Mofetil to Enteric-coated Mycophenolate Sodium (myfortic) in a Patient with Graft-versus-host Disease. Drugs 66(2 Supplement): 29-31, 2006