Overview
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 initial or second-line 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.
Description
OUTLINE
Patients complete questionnaires over 10 minutes about physical symptoms, activity level, and emotional well-being and have their medical records reviewed at baseline, 1, 3, and 6 months after starting index treatment, and at start of a new systemic treatment. Patients also undergo collection of blood samples over 1-2 minutes at baseline and at 1 month after starting index treatment, or at a treatment change visit if new therapy has not started.
Eligibility
Inclusion Criteria:
- 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 initial or second-line treatment is started (may be concurrent with the enrollment visit), and later between 2-6 weeks, 3 months and 6 months after treatment is started or if a new therapy is started before 6 months
- Signed, informed consent
Exclusion Criteria:
- Inability to comply with study procedures
- Uncontrolled psychiatric disorder
- Anticipated survival < 6 months