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Blood, 16 July 2009, Vol. 114, No. 3, pp. 511-517. Prepublished online as a Blood First Edition Paper on May 14, 2009; DOI 10.1182/blood-2009-03-212290. This Article Full Text Full Text (PDF) Supplemental Appendix All Versions of this Article: blood-2009-03-212290v1 114/3/511    most recent Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Google Scholar Articles by Alousi, A. M. Articles by Levine, J. E. PubMed PubMed Citation Articles by Alousi, A. M. Articles by Levine, J. E. Related Collections Transplantation Free Research Articles Clinical Trials and Observations Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  CLINICAL TRIALS AND OBSERVATIONS Etanercept, mycophenolate, denileukin, or pentostatin plus corticosteroids for acute graft-versus-host disease: a randomized phase 2 trial from the Blood and Marrow Transplant Clinical Trials Network Amin M. Alousi1, Daniel J. Weisdorf2, Brent R. Logan3, Javier Bolaños-Meade4, Shelly Carter5, Nancy DiFronzo6, Marcelo Pasquini7, Steven C. Goldstein8, Vincent T. Ho9, Brandon Hayes-Lattin10, John R. Wingard11, Mary M. Horowitz12, John E. Levine13, on behalf of the Blood and Marrow Transplant Clinical Trials Network 1 Department of Stem Cell Transplantation and Cellular Therapy, University of Texas M. D. Anderson Cancer Center, Houston; 2 Department of Bone Marrow Transplantation, University of Minnesota, Minneapolis; 3 Department of Population Health, Medical College of Wisconsin, Milwaukee; 4 Department of Oncology, The Johns Hopkins University, Baltimore, MD; 5 The EMMES Corporation, Rockville, MD; 6 Transfusion Medicine and Cellular Therapeutics Branch, National Heart, Lung, and Blood Institute, National Institutes of Health/Department of Health and Human Services, Bethesda, MD; 7 Division of Neoplastic Diseases and Related Disorders, Department of Medicine, Center for International Blood and Marrow Transplant Research (CIBMTR) Medical College of Wisconsin, Milwaukee; 8 Division of Hematology/Oncology, University of Pennsylvania, Philadelphia; 9 Department of Medical Oncology/Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, MA; 10 School of Medicine, Oregon Health and Science University, Portland; 11 Department of Medicine, University of Florida Shands Cancer Center, Gainesville; 12 Division of Neoplastic Diseases and Related Disorders, Department of Medicine, and CIBMTR, Froedtert and The Medical College of Wisconsin, Milwaukee; and 13 Department of Pediatrics and Communicable Diseases, University of Michigan, Ann Arbor Acute graft-versus-host disease (aGVHD) is the primary limitation of allogeneic hematopoietic cell transplantation. Corticosteroids remain the standard initial therapy, yet only 25% to 41% of patients completely respond. This randomized, 4-arm, phase 2 trial was designed to identify the most promising agent(s) for initial therapy for aGVHD. Patients were randomized to receive methylprednisolone 2 mg/kg per day plus etanercept, mycophenolate mofetil (MMF), denileukin diftitox (denileukin), or pentostatin. Patients (n = 180) were randomized; their median age was 50 years (range, 7.5-70 years). Myeloablative conditioning represented 66% of transplants. Grafts were peripheral blood (61%), bone marrow (25%), or umbilical cord blood (14%); 53% were from unrelated donors. Patients who received MMF for prophylaxis (24%) were randomized to a non-MMF arm. At randomization, aGVHD was grade I to II (68%), III to IV (32%), and (53%) had visceral organ involvement. Day 28 complete response rates were etanercept 26%, MMF 60%, denileukin 53%, and pentostatin 38%. Corresponding 9-month overall survival was 47%, 64%, 49%, and 47%, respectively. Cumulative incidences of severe infections were as follows: etanercept 48%, MMF 44%, denileukin 62%, and pentostatin 57%. Efficacy and toxicity data suggest the use of MMF plus corticosteroids is the most promising regimen to compare against corticosteroids alone in a definitive phase 3 trial. This study is registered at http://www.clinicaltrials.gov as NCT00224874 [ClinicalTrials.gov] . CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: G. Socie and B. R. Blazar Acute graft-versus-host disease: from the bench to the bedside Blood, November 12, 2009; 114(20): 4327 - 4336. [Abstract] [Full Text] [PDF]

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