This trial collects clinical data and blood samples to predict the quality of response to specific treatments in patients with chronic graft-versus-host disease (cGVHD) who are about to start a new therapy. Collecting and analyzing clinical data and blood samples from patients with cGVHD before and after treatment initiation may help doctors identify changes that may predict treatment response.
Adults age 18 or older
Prior allogeneic stem cell transplant, with any graft source, donor type, and GVHD prophylaxis
No evidence of persistent or progressive malignancy at the time of enrollment
Agrees to be evaluated at the transplant center before a new line of treatment is started (may be concurrent with the enrollment visit), and later between 2-6 weeks, 3 months and 6 months after index treatment is started or if an additional new therapy is started before 6 months
Inability to comply with study procedures
Uncontrolled psychiatric disorder
Anticipated survival < 6 months
Patients with chronic graft-versus-host disease (GVHD) who are starting a new therapy for GVHD
Cohort
Prospective
Biospecimen Collection
Procedure/SurgeryUndergo collection of blood sample
Medical Chart Review
Other interventionReview of medical chart
Quality-of-Life Assessment
Other interventionAncillary studies
Questionnaire Administration
Other interventionComplete questionnaire
Clinical Response according to the 2014 criteria
At the assessments, the 9 provider-reported National Institute of Health (NIH) organ severity scores (skin, eye, mouth, esophagus, upper gastrointestinal \[GI\], lower GI, liver, lung, and joint manifestations) will be collected reflecting disease activity in the past week. All scored items are single 4-7 point Likert scales. Based on past work, we anticipate it will take approximately 8 minutes to conduct the physical exam and record the relevant results. Pulmonary function testing results will be collected if available. Response will be assessed according to the recommendations of the 2014 NIH response measures publication or any applicable updates.
Time to next systemic treatment
Any addition of another systemic cGVHD treatment for medical reasons will be considered a failure, whether added because of a new or worsening manifestation of cGVHD, used as a "steroid sparing agent," or substituted due to toxicity.
Duration of treatment
Duration of treatment is defined as the time until discontinuation of therapeutic systemic immunosuppression (adrenal replacement and topical/local therapies are allowed) without resumption for at least 3 months.
Survival
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Fred Hutchinson Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
