Observational study for patients at risk of chronic graft-versus-host disease
A Prospective, Observational Cohort Study of Participants at Risk for Chronic Graft-Versus-Host Disease in the United States (THRIVE)
This study is tracking the health of people who have recently had a stem cell transplant to see if they develop chronic graft-versus-host disease over the next few months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Incyte Corporation Industry-sponsored |
| Locations | 32 sites (Birmingham, Alabama and 31 other locations) |
| Trial ID | NCT05919511 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather data from individuals who have recently undergone an allogenic stem cell transplant and are at risk for developing chronic graft-versus-host disease (cGVHD). Participants will be monitored for 90 to 180 days post-transplant to assess their health and any signs of cGVHD. The study is non-interventional, meaning no additional treatments will be administered as part of the study. Data collected will help improve understanding and management of cGVHD in transplant patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone an allogeneic stem cell transplant within the last 90 to 180 days.
Not a fit: Patients who have not had an allogeneic stem cell transplant or are outside the specified time frame will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of cGVHD and lead to better management strategies for patients at risk.
How similar studies have performed: While this study is observational, similar studies have successfully contributed to the understanding of cGVHD and its management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years inclusive at the time of signing the ICF * Allogeneic SCT 90 to 180 days prior to enrollment * Able to comprehend and willing to provide informed consent * Willing and able to complete participant-assessment questionnaires either alone or with minimal assistance from a caregiver and/or trained site personnel Exclusion Criteria: * There are no exclusion criteria for this study
Where this trial is running
Birmingham, Alabama and 31 other locations
- University of Alabama Birmingham — Birmingham, Alabama, United States (Recruiting)
- Mayo Clinic Arizona — Phoenix, Arizona, United States (Recruiting)
- City of Hope — Duarte, California, United States (Recruiting)
- USC Norris Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)
- University of Colorado — Aurora, Colorado, United States (Recruiting)
- Mayo Clinic Jacksonville — Jacksonville, Florida, United States (Recruiting)
- AdventHealth Orlando — Orlando, Florida, United States (Recruiting)
- Moffit Cancer Center — Orlando, Florida, United States (Recruiting)
- Emory University — Atlanta, Georgia, United States (Recruiting)
- Georgia Cancer Center — Augusta, Georgia, United States (Recruiting)
- Northwestern University — Chicago, Illinois, United States (Recruiting)
- Rush University Medical Group — Chicago, Illinois, United States (Recruiting)
- The University of Chicago — Chicago, Illinois, United States (Recruiting)
- Loyola University Medical Center — Maywood, Illinois, United States (Recruiting)
- The University of Kansas Clinical Research Center — Fairway, Kansas, United States (Recruiting)
- Tulane Cancer Center — New Orleans, Louisiana, United States (Completed)
- University of Maryland Medical Center — Baltimore, Maryland, United States (Recruiting)
- Massachusetts Cancer Research Center — Boston, Massachusetts, United States (Recruiting)
- Corewell Health — Grand Rapids, Michigan, United States (Recruiting)
- Mayo Clinic Rochester — Rochester, Minnesota, United States (Recruiting)
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
- Levine Cancer Institute — Charlotte, North Carolina, United States (Recruiting)
- The Ohio State University — Columbus, Ohio, United States (Recruiting)
- Oregon Health Sciences University — Portland, Oregon, United States (Recruiting)
- Geisinger Health Systems — Danville, Pennsylvania, United States (Recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
- Texas Oncology-Baylor Charles A. Sammons Cancer Center — Dallas, Texas, United States (Recruiting)
- University of Utah, Huntsman Cancer Institute — Salt Lake City, Utah, United States (Recruiting)
- Fred Hutchinson Cancer Research Center — Seattle, Washington, United States (Recruiting)
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Incyte Corporation Call Center (US)
- Email: medinfo@incyte.com
- Phone: 1.855.463.3463
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.