The problem of chronic graft-versus-host disease (cGVHD) for allogeneic hematopoietic cell transplant (alloHCT) patients is incredibly pervasive. However, there is surprisingly little centralization of outcomes and disease-course data. One currently enrolling study seeks to change that.
The THRIVE study is a prospective, longitudinal, observational study of United States alloHCT recipients that primarily seeks to “assess the clinical course and burden of cGVHD, including cGVHD diagnosis and severity recorded in electronic case report forms (eCRFs) and [patient]-reported outcome measures (PROMs).”
“Our current understanding of cGVHD is largely based on data from registries, small prospective studies, and the cGVHD Consortium with representation from tertiary care academic centers. Prospective studies of a more representative and generalizable sample of patients…at risk for cGVHD over a prolonged follow-up and including a non-cGVHD control population are limited,” Areej R. El-Jawahri of Massachusetts General Hospital, Boston, Massachusetts, explained.
“This study aims to add to this growing body of data with a broad [patient]-centered assessment of post-alloHCT medical and psychosocial complications and caregiver involvement in a diverse and contemporary pt population,” the team reported.
There are 13 different PROMs, including but not limited to oral health, ocular surface disease, pulmonary symptoms, anxiety, and involvement of caregivers.
Participants in this study will be followed for 36 months from enrollment. As many as 1500 patients (including 500 controls) will be recruited.
El-Jawahri AR, Khera N, Lee CJ, et al. Trial in Progress: A Prospective, Observational Cohort Study of Patients at Risk for Chronic Graft-Versus-Host Disease in the United States (THRIVE). Abstract #371. Presented at the 2023 Tandem Meetings of ASTCT and CIBMTR; February 15-19, 2023; Orlando, FL.