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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.


DateTopic​​Presenter(s)​Materials Available
8:15 AM​​WelcomeCelia Witten, PhD, MD, FDA/CBER/OCTGT​No
8:25 AM​Introduction​Nancy DiFronzo, PhD, NHLBI​Yes
8:30 AMGVHD Prevention TrialsYes
What are the regulatory issues that impact endpoints for prevention trials?Ann Farrell, MD, FDA/OODP/DDOP
Acute GVHD: Grading and EndpointsPaul Martin, MD, Fred Hutchinson Cancer Research Center, Seattle, WA
Issues In Designing GVHD Prevention TrialsMary Horowitz, MD, MS, CIBMTR, Milwaukee, WI
10:00 AM​Panel Discussion and Questions​No
10:15 AM​Break​No
10:30 AMStatistical Considerations and BiomarkersYes
Three Methods for Phase I/II Clinical Trials, with Application to Allogeneic Stem Cell TransplantationPeter Thall, PhD, U T MD Anderson Cancer Center, Houston, TX
Phase II and III Study Designs for Acute GVHDBrent Logan, PhD, CIBMTR, Milwaukee, WI
Biomarkers for Acute GVHDJohn 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 PMGVHD Treatment TrialsYes
Issues For Design of Acute GVHD Treatment TrialsDonna Przepiorka, MD, PhD, FDA/CBER/OCTGT/DCEPT
Clinical Trial Endpoints for Patients with Acute GVHDAmin 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 PMPatient-Reported Outcomes

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 PMWrap 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 1:42 PM