NIH Chronic GVHD Consensus Project

Finding Solutions for Chronic GVHD

ASBMT offers its members the information, tools and forms they need to stay informed and involved in efforts to develop more effective treatments for chronic graft-versus-host disease (chronic GVHD) — an urgent unmet clinical need and the most frequent complication after HCT. On our website, our members will find:

• Information on measuring therapeutic response and collecting data in chronic GVHD-related clinical trials
• Proposed endpoints and supporting data for chronic GVHD treatment trials
• Histopathology forms for consultation information requests and background information about their use
• Information on major changes in 2014 to the recommendations for ancillary therapy and supportive care

Measuring Chronic GVHD Therapeutic Response

The links below go to information for measuring therapeutic response in chronic GVHD-related clinical trials and data collection forms.

Slides on Measuring Response

• Overview of Chronic GVHD Response Assessment, Steven Z. Pavletic, M.D., National Cancer Institute, NIH
• Oral Manifestations, Mark M. Schubert, DDS, MSD, Fred Hutchinson Cancer Research Center
• Ocular Manifestations, Stella K. Kim, M.D., MD Anderson Cancer Center, and Michael R. Robinson, M.D., National Eye Institute, NIH

2014 NIH Consensus Updated Response Criteria Forms

• 2014 Response Criteria Appendix A: Data Collection Form A – Clinical Assessment
• 2014 Response Criteria Appendix B: Data Collection Form B – Patient Self Report

For more information about this updated GVHD measurement system, see 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. The 2014 Response Criteria Working Group Report.

2005 NIH Consensus Response Criteria Forms

• 2005 Response Criteria Appendix A: Data Collection Form A – Clinical Assessment
• 2005 Response Criteria Appendix B: Data Collection Form B – Patient Self Report
• 2005 Response Criteria Appendices C & D: Proposed Calculations for Partial Response in Chronic GVHD and Proposed Calculations for Progression in Chronic GVHD

Other 2005 NIH Consensus Documents

• 2005 Response Criteria Attachment 1: Literature Review of Various Response Criteria Used in Chronic Graft-Versus-Host Disease Clinical Trials
• 2005 Response Criteria Attachment 2: Glossary
• 2005 Response Criteria Attachment 3: Skin Body Surface Area Calculation Worksheet
• 2005 Response Criteria Attachment 4: Body Surface Area Assessment in Children Younger Than 1 Year of Age
• 2005 Response Criteria Attachment 5: Patient Reported Outcome Measure Recommended for Chronic GVHD Response

For more information about this measurement system, see Measuring Therapeutic Response in Chronic Graft-versus-Host Disease: National Institutes of Health Consensus Development Project for Clinical Trials in Graft-versus-Host Disease: IV. Response Criteria Working Group Report.

Proposed Endpoints for Evaluating Clinical Trials

The briefing materials contain information submitted to the FDA by members of the Clinical Trial Design Working Group, in preparation for a formal Pre-Investigational New Drug (PIND) meeting on Jan. 28, 2015, to discuss possible endpoints in clinical trials to evaluate products for treatment of chronic GVHD. The meeting was not intended to discuss any specific products.

The briefing document includes a cover letter, background information and an extensive presentation of data relevant to five proposed endpoints for chronic GVHD treatment trials, including 21 tables, eight figures, 63 references, three supplementary tables and 15 appendices. The document also includes preliminary queries from the FDA, a response to the FDA and a copy of the official meeting minutes.

You also can read the abstract and full text of the 2014 Clinical Trial Design Working Group Report.

Histopathology Forms

This Consultation Information Request Form document includes the following:

• Sample cover letter requesting clinical information with request for pathology consultation
• Form A — Liver Consultation Clinical Information Form
• Form B — Protocol Evaluation of Liver Biopsies
• Form C — Gastrointestinal Biopsy Clinical Information
• Form D — Protocol Evaluation of Gut Biopsies
• Form E — Cutaneous Consultation Clinical Information Form
• Form F — Protocol Evaluation of Cutaneous Biopsies
• Form G — Oral Mucosa Consultation Clinical Information Form
• Form H — Protocol Evaluation of Mucosal Biopsies

For background information about use of the histopathology forms, see 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.

Recommendations for Ancillary and Supportive Care

The 2006 NIH Consensus paper presented recommendations by its Ancillary Therapy and Supportive Care Working Group to support clinical research trials in chronic GVHD. Topics covered in that inaugural effort included the prevention and management of infections and common complications of chronic GVHD, as well as recommendations for patient education and appropriate follow-up.

Because of the literature that was published in the eight years following that paper, the working group made organ-specific refinements to those guidelines in 2014. Using the framework of the prior consensus, the 2014 recommendations are organized by organ or other relevant systems and graded according to the strength and quality of supporting evidence.

• Read a summary of the changes to the 2005 recommendations for ancillary therapy and supportive care.
• Read the working group's 2014 report.