Polyomic Biomarker Verification in Adult Chronic Graft-Versus-Host Disease. Applied Biomarkers in Late Effects (ABLE) 3.0 (CTTC 2201)
Categories (click each to see list of all clinical trials associated with that category): Leukemia/MDS/MPD (ONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Bhatt, Vijaya
Contact Information:
Penny Hardiman, RN
402-559-4135
penny.hardiman@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT05692713?term=NCT05692713&rank=1
Summary
PRIMARY OBJECTIVE
Validate and implement a pediatric-based risk-assignment biomarker algorithm at day +100 (+/- 14 days) that predicts the future risk of chronic (cGvHD) and late-acute GvHD (L-aGvHD), and based upon these results, group study participants into "risk groups" that predict a future high-risk (>45%), intermediate-risk (10-45%), or low risk (< 10%) for the development of L-aGvHD and cGvHD.
SECONDARY OBJECTIVES
1. Determine the possibility of a biomarker risk-assignment at day +60 (+/- 7 days) that will identify study participants at risk for developing cGvHD early post-transplant (between days 70 -114) and include them in the biomarker algorithm.
2. Develop the Biomarker panels at the onset of both late acute and chronic GvHD, based on differences in biomarker expression profile.