Biology of Blood and Marrow Transplantation
Volume 12, Issue 5 , Pages 491-505 , May 2006

National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: VI. Design of Clinical Trials Working Group Report

  • Paul J. Martin

      Affiliations

    • Fred Hutchinson Cancer Research Center, University of Washington School of Medicine, Seattle, Washington
    • Corresponding Author InformationCorrespondence and reprint requests: Paul J. Martin, MD, Fred Hutchinson Cancer Research Center, PO Box 19024, 1100 Fairview Avenue N, D2-100, Seattle, WA 98109-1024
    • ,
  • Daniel Weisdorf

      Affiliations

    • University of Minnesota, Minneapolis, Minnesota
    • ,
  • Donna Przepiorka

      Affiliations

    • University of Tennessee, Memphis, Tennessee
    • ,
  • Steven Hirschfeld

      Affiliations

    • US Food and Drug Administration, Rockville, Maryland
    • ,
  • Ann Farrell

      Affiliations

    • US Food and Drug Administration, Rockville, Maryland
    • ,
  • J. Douglas Rizzo

      Affiliations

    • Medical College of Wisconsin, Milwaukee, Wisconsin
    • ,
  • Ronan Foley

      Affiliations

    • McMaster University, Hamilton, Ontario, Canada
    • ,
  • Gerard Socie

      Affiliations

    • Hopital St. Louis, Paris, France
    • ,
  • Shelly Carter

      Affiliations

    • EMMES Corporation, Rockville, Maryland
    • ,
  • Daniel Couriel

      Affiliations

    • University of Texas M.D. Anderson Cancer Center, Houston, Texas
    • ,
  • Kirk R. Schultz

      Affiliations

    • British Columbia Children’s Hospital, University of British Columbia, Vancouver, British Columbia, Canada
    • ,
  • Mary E.D. Flowers

      Affiliations

    • Fred Hutchinson Cancer Research Center, University of Washington School of Medicine, Seattle, Washington
    • ,
  • Alexandra H. Filipovich

      Affiliations

    • Cincinnati Children’s Hospital Medical Center, University of Cincinnati, Cincinnati, Ohio
    • ,
  • Rima Saliba

      Affiliations

    • University of Texas M.D. Anderson Cancer Center, Houston, Texas
    • ,
  • Georgia B. Vogelsang

      Affiliations

    • Johns Hopkins University School of Medicine, Baltimore, Maryland
    • ,
  • Steven Z. Pavletic

      Affiliations

    • National Cancer Institute, National Institutes of Health, Bethesda, Maryland
    • ,
  • Stephanie J. Lee

      Affiliations

    • Fred Hutchinson Cancer Research Center, University of Washington School of Medicine, Seattle, Washington

Received 8 March 2006 ,Accepted 9 March 2006.

References 

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  2. Stewart BL , Storer B , Storek J , et al.   Duration of immunosuppressive treatment for chronic graft-versus-host disease . Blood . 2004;104:3501–3506
  3. Filipovich AH , Weisdorf D , Pavletic S , et al.   National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and Staging Working Group report . Biol Blood Marrow Transplant . 2005;11:945–955
  4. Shulman HM , Kleiner D , Lee SJ , et al.   Histopathologic diagnosis of chronic graft-versus-host disease: National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: II. Pathology Working Group report . Biol Blood Marrow Transplant . 2006;12:31–47
  5. Couriel D , Carpenter P , Cutler C , et al.   Ancillary therapy and supportive care of chronic graft-versus-host disease: National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: V. Ancillary Therapy and Supportive Care Working Group report . Biol Blood Marrow Transplant . 2006;12:375–396
  6. Pavletic SZ , Martin P , Lee SJ , et al.   Measuring therapeutic response in chronic graft-versus-host disease: National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: IV. Response Criteria Working Group report . Biol Blood Marrow Transplant . 2006;12:252–266
  7. Lee SJ , Vogelsang GB , Flowers MED . Chronic graft-versus-host disease . Biol Blood Marrow Transplant . 2003;9:215–233
  8. International Conference on Harmonization. Guidelines for good clinical practice . 1996; Geneva, Switzerland; May 1
  9. Wittes RE . Antineoplastic agents and FDA regulations (square pegs for round holes?) . Cancer Treat Rep . 1987;71:795–806
  10. American Society of Clinical Oncology . Outcomes of cancer treatment for technology assessment and cancer treatment guidelines . J Clin Oncol . 1996;14:671–679
  11. Chao NJ , Parker PM , Niland JC , et al.   Paradoxical effect of thalidomide prophylaxis on chronic graft-vs-host disease . Biol Blood Marrow Transplant . 1996;2:86–92
  12. Koc S , Leisenring W , Flowers ME , et al.   Thalidomide for treatment of patients with chronic graft-versus-host disease . Blood . 2000;96:3995–3996
  13. Arora M , Wagner JE , Davies SM , et al.   Randomized clinical trial of thalidomide, cyclosporine, and prednisone versus cyclosporine and prednisone as initial therapy for chronic graft- versus-host disease . Biol Blood Marrow Transplant . 2001;7:265–273
  14. Food and Drug Administration . Guidance for Industry (Special Protocol Assessment) . Rockville, MD: Food and Drug Administration; 2002;
  15. 21 Code of Federal Regulations 324.126, 2005.
  16. Schultz KR , Miklos DB , Fowler D , et al.   Toward biomarkers for chronic graft-versus-host disease: National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: III. Biomarker Working Group report . Biol Blood Marrow Transplant . 2006;12:126–137
  17. Harter JG , Reddy WJ , Thorn GW . Studies on an intermittent corticosteroid dosage regimen . N Engl J Med . 1963;269:591–596
  18. Fauci AS , Dale DC . Alternate-day prednisone therapy and human lymphocyte subpopulations . J Clin Invest . 1975;55:22–32

 The opinions expressed here are those of the authors and do not represent the official position of the National Institutes of Health, US Food and Drug Administration, or the US Government.

PII: S1083-8791(06)00250-3

doi: 10.1016/j.bbmt.2006.03.004

Biology of Blood and Marrow Transplantation
Volume 12, Issue 5 , Pages 491-505 , May 2006

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