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Acute Graft-versus-Host Disease (GVHD) Workshop

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Acute Graft-versus-Host Disease (GVHD) Workshop

In May 2009, scientific leaders gathered for a full-day workshop entitled, “Workshop on Clinical Trial Endpoints for Acute Graft-vs-Host Disease after Allogeneic Hematopoietic Stem Cell Transplantation”. The purpose of this workshop was to review data that will serve as the foundation for protocol design and clinical trial evidence-based endpoints intended to support the approval of new drugs or biologics to prevent or treat acute GVHD.

Workshop topics included:

  • Regulatory issues related to GVHD trials
  • Diagnosis and grading of acute GVHD
  • Endpoints for acute GVHD prevention trials
  • Endpoints for acute GVHD treatment trials
  • Statistical ways to minimize confounding factors
  • Biomarkers for acute GVHD
  • Patient-reported outcomes for acute GVHD trials
Access the workshop agenda and slides below.
 
​Date Topic​ ​Presenter(s) ​Materials Available
8:15 AM​ ​Welcome Celia Witten, PhD, MD, FDA/CBER/OCTGT ​No
​8:25 AM ​Introduction ​Nancy DiFronzo, PhD, NHLBI ​Yes
8:30 AM GVHD Prevention Trials Yes
What are the regulatory issues that impact endpoints for prevention trials? Ann Farrell, MD, FDA/OODP/DDOP
Acute GVHD: Grading and Endpoints Paul Martin, MD, Fred Hutchinson Cancer Research Center, Seattle, WA
Issues In Designing GVHD Prevention Trials Mary Horowitz, MD, MS, CIBMTR, Milwaukee, WI
​10:00 AM ​Panel Discussion and Questions ​No
​10:15 AM ​Break ​No
10:30 AM Statistical Considerations and Biomarkers Yes
Three Methods for Phase I/II Clinical Trials, with Application to Allogeneic Stem Cell Transplantation Peter Thall, PhD, U T MD Anderson Cancer Center, Houston, TX
Phase II and III Study Designs for Acute GVHD Brent Logan, PhD, CIBMTR, Milwaukee, WI
Biomarkers for Acute GVHD John Hansen, MD, PhD, Fred Hutchinson Cancer Research Center, Seattle, WA
​12:00 PM ​Panel Discussion and Questions ​No
​12:30 PM ​Lunch ​No
1:15 PM GVHD Treatment Trials Yes
Issues For Design of Acute GVHD Treatment Trials Donna Przepiorka, MD, PhD, FDA/CBER/OCTGT/DCEPT
Clinical Trial Endpoints for Patients with Acute GVHD Amin Alousi, MD, U T MD Anderson Cancer Center, Houston, TX
Treatment of Acute GVHD: Predictors of Survival ​Dan Weisdorf, MD, University of Minnesota, Minneapolis, MN
Defining Response in GVHD Treatment Trials ​Paul Carpenter, MD, Fred Hutchinson Cancer Research Center, Seattle, WA
​3:15 PM ​Break
​3:30 PM Patient-Reported Outcomes
​Yes
Patient-Reported Outcomes (PROs) for GVHD Prevention and Treatment Trials ​Stephanie Lee, MD, MPH, Fred Hutchinson Cancer Research Center, Seattle, WA
4:00 PM​ ​Panel Discussion and Questions ​No
4:50 PM Wrap Up ​Steven Pavletic, MD, NCI ​Yes
​5:00 PM ​Adjourn
 
 
This workshop was co-sponsored by the National Heart, Lung, and Blood Institute (NHLBI), National Cancer Institute (NCI), Food and Drug Administration (FDA), Center for International Blood and Marrow Transplant Research (CIBMTR), American Society for Blood and Marrow Transplantation (ASBMT) and National Institute of Allergy and Infectious Diseases (NIAID).

Last Updated: 3/27/2017 10:49 AM
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