Chronic GVHD Response Measures Validation
The purpose of this study is to develop and validate endpoint measures that can accurately determine whether patients are responding to treatment for chronic Graft-versus-Host Disease (GVHD). Hopefully, this will also lead to being better able to predict which patients will respond to what therapies.
Graft vs Host Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Chronic GVHD Response Measures Validation|
- Develop and validate the Chronic GVHD-Activity Index (CGVHD-AI) as a measure of treatment response. [ Time Frame: 18 months ] [ Designated as safety issue: No ]This measure is intended to capture impairments caused by chronic GVHD. We expect that change in the CGVHD-AI could be used to measure treatment response because it will correlate with clinically significant changes reported by physicians and patients. The CGVHD-AI would be most appropriate for use in clinical trials where the goal is symptom relief and decreased disease activity.
- To develop and validate the Chronic GVHD Failure-Free Survival Score (CGVHD-FFS) as a predictor of failure-free survival. [ Time Frame: 18 months ] [ Designated as safety issue: No ]This measure is intended for use as an intermediate endpoint that predicts subsequent failure-free survival, defined as absence of death, relapse and requirement for new therapy, i.e., events that constitute treatment failures in clinical trials. The CGVHD-FFS would be most appropriate for phase II and III trials testing agents intended to change the underlying biology of the syndrome, for example by inducing immunologic tolerance.
Biospecimen Retention: Samples With DNA
Whole blood samples (30mL) processed for peripheral blood mononuclear cells (PBMC), plasma, and granulocytes.
|Study Start Date:||June 2013|
|Estimated Primary Completion Date:||June 2018 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01902576
|Contact: Evangelyn Nkwopara, MS||(206) email@example.com|
|United States, Washington|
|Fred Hutchinson Cancer Research Center||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Evangelyn Nkwopara, MS 206-667-6830 firstname.lastname@example.org|
|Principal Investigator: Stephanie J Lee, MD MPH|
|Principal Investigator:||Stephanie J Lee, MD MPH||Fred Hutchinson Cancer Research Center|