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Spacer NIH 2014 Chronic GVHD Consensus Project on Criteria for Clinical Trials

NIH 2014 Chronic GVHD Consensus Project on Criteria for Clinical Trials

Tuesday, June 17, 2014
National Cancer Institute at Shady Grove
(NOT THE BETHESDA CAMPUS!)

9609 Medical Center Drive
Rockville, MD 20850
Shady Grove Room TE406

Important Note:
All draft documents are available now for public comments until August 15, 2014 on our Additional Resources page. Please email your comments, suggestions and queries to Drs. Steven Pavletic (pavletis@mail.nih.gov), Georgia Vogelsang (gbvogelsang@gmail.com), and Stephanie Lee (sjlee@fhcrc.org), cc to Ms. Licia Masuch (licia.masuch@nih.gov).

Chronic GVHD (cGVHD) is an area of profound unmet need. Currently there are no FDA approved therapeutics for cGVHD, and the incidence of this complication among the transplant patient population is rising. The purpose of this one day conference is to provide a set of updated evidence-based recommendations for the conduct of cGVHD clinical trials and research. During the period of 2004-2006, the original NIH cGVHD Consensus Project provided expert-driven recommendations, which were summarized in six papers covering key areas: diagnosis and staging; histopathology; biomarkers; response criteria; ancillary and supportive care and design of clinical trials. These papers have been cited more than 1400 times in peer-reviewed literature. The research field in cGVHD is now better organized and research momentum has intensified. However, there is a need for evidence-based refinements and clarifications of the original recommendations. There is also a need to develop response criteria qualified for regulatory approval of new agents. It is necessary to now develop a cGVHD activity index, qualified biomarkers and new treatments, within the framework of emerging knowledge of the pathobiology of the disease. This meeting will thoroughly address these critical questions and respective manuscripts will be submitted for publication. This conference is open to all stakeholders, and will include intensive schedule of in depth presentations of the working group reports, expert panels and discussions. Working group documents will be posted on this website in May in advance of the meeting.

Project Chairs

Steven Pavletic, Center for Cancer Research, NCI, Bethesda
Georgia Vogelsang, Johns Hopkins University, Baltimore
Stephanie Lee, Fred Hutchinson Cancer Research Center, Seattle

Working Groups and chairs:

I. Diagnosis and Staging Working Group
Mary Flowers, (co-chair), Fred Hutchinson Cancer Research Center, Seattle
Madan Jagasia (co-chair), Vanderbilt University Medical Center, Nashville

II. Histopathology Working Group
David Kleiner (co-chair), Center for Cancer Research, NCI, Bethesda
Howard Shulman (co-chair), Fred Hutchinson Cancer Research Center, Seattle

III. Biomarkers and Biology Working Group
Kirk Schultz (co-chair), British Columbia Children's Hospital and Family Research Institute, Vancouver
Sophie Paczesny (co-chair), Indiana University School of Medicine, Indianapolis

IV. Response Criteria Working Group
Steven Pavletic (co-chair), Center for Cancer Research, NCI, Bethesda
Stephanie Lee (co-chair), Fred Hutchinson Cancer Research Center, Seattle

V. Ancillary and Supportive Working Group
Dan Couriel (co-chair), University of Michigan Comprehensive Cancer Center, Ann Arbor
Paul Carpenter (co-chair), Fred Hutchinson Cancer Research Center, Seattle

VI. Design of Clinical Trials Working Group
Paul Martin (co-chair), Fred Hutchinson Cancer Research Center, Seattle
Corey Cutler (co-chair), Dana-Farber Cancer Institute, Boston

Steering committee ex officio members:

Roy Wu, NCI; William Merritt, NCI; Linda Griffith, NIAID, Nancy DiFronzo, NHLBI; Myra Jacobs, National BMTLink; Susan Stewart, BMTInfoNet; Meredith Cowden, Meredith Cowden GVHD Foundation.
General Information

For conference related questions please contact Licia Masuch
301.435.9352

Location


National Cancer Institute - Shady Grove
9609 Medical Center Drive
Rockville, MD 20850
Shady Grove Room TE406

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