A Prospective, Observational Cohort Study of Participants at Risk for Chronic Graft-Versus-Host Disease in the United States (THRIVE)
Primary:
Describe the clinical course and burden of cGVHD after alloSCT
Secondary:
Describe personal and healthcare resource utilization associated with the management of
cGVHD
Describe practice patterns and therapy strategies in participants treated for cGVHD in both
community and academic settings, including frequency, safety, and effectiveness of steroids
Assess the impact of SCT and cGVHD on organ specific symptoms as reported by participants
Assess the predictive, diagnostic, and prognostic
Exploratory:
Explore the burden of steroid treatment on participants
Determine the risk factors for cGVHD
Determine the association of the development
and severity of cGVHD with the history of aGVHD
Determine the risk factors for the progression from mild to moderate or severe cGVHD
Determine incidence of post-SCT infection and malignancy
Determine utilization of post-transplant vaccines
Assess the predictive, diagnostic, and prognostic associations of specific blood and
saliva protein and molecular markers with cGVHD
- Rutgers Cancer Institute of New Jersey
- Principal Investigator
- Amer Assal MD
- Principal Investigator
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
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356.