Predicting treatment response in patients with chronic graft-versus-host disease
Predicting the Quality of Response to Specific Treatments (PQRST)
This study is trying to see if collecting health information and blood samples from patients with chronic graft-versus-host disease can help predict how well they will respond to new treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fred Hutchinson Cancer Center Academic / other |
| Locations | 10 sites (Gainesville, Florida and 9 other locations) |
| Trial ID | NCT04431479 on ClinicalTrials.gov |
What this trial studies
This observational study collects clinical data and blood samples from patients with chronic graft-versus-host disease (cGVHD) who are about to start a new therapy. Patients will complete questionnaires regarding their physical symptoms, activity level, and emotional well-being, while their medical records will be reviewed at various intervals. Blood samples will also be collected at baseline and one month after starting treatment or at the time of a treatment change. The goal is to identify changes that may predict how well patients respond to specific treatments.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 or older who have undergone an allogeneic stem cell transplant and are about to start a new line of treatment for cGVHD.
Not a fit: Patients with uncontrolled psychiatric disorders or those with an anticipated survival of less than six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help doctors better predict treatment responses in patients with cGVHD, leading to more personalized and effective therapies.
How similar studies have performed: Other studies have shown promise in predicting treatment responses in similar patient populations, suggesting that this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 * Signed, informed consent Exclusion Criteria: * Inability to comply with study procedures * Uncontrolled psychiatric disorder * Anticipated survival \< 6 months
Where this trial is running
Gainesville, Florida and 9 other locations
- University of Florida — Gainesville, Florida, United States (Completed)
- Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
- Dana-Farber Harvard Cancer Center — Boston, Massachusetts, United States (Recruiting)
- University of Minnesota/Masonic Cancer Center — Minneapolis, Minnesota, United States (Completed)
- Roswell Park Cancer Institute — Buffalo, New York, United States (Completed)
- Cleveland Clinic Foundation — Cleveland, Ohio, United States (Recruiting)
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (Completed)
- Vanderbilt University/Ingram Cancer Center — Nashville, Tennessee, United States (Completed)
- Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States (Recruiting)
- Vancouver General Hospital/BC Cancer — Vancouver, British Columbia, Canada (Completed)
Study contacts
- Principal investigator: Stephanie J. Lee — Fred Hutch/University of Washington Cancer Consortium
- Study coordinator: Gaby Desatnik
- Email: cgvhd@fredhutch.org
- Phone: 206-667-1356
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.