eligibility_summary
Eligible: first-episode, systemic therapy–requiring classic cGVHD (no aGVHD features), previously untreated (<10 days steroids/other IS), KPS ≥70%, ANC >750 and platelets >30k without transfusion/G‑CSF x7 days. Exclude: late/recurrent aGVHD, uncontrolled infection, HIV, active HBV/HCV unless PCR–, CrCl <30 mL/min, AST/ALT >5×ULN or direct bili >3×ULN, EF <40%/uncontrolled arrhythmias, >1 prior allogeneic transplant.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, single-arm trial for primary treatment of extensive chronic GVHD testing: 1) Belumosudil—an oral small-molecule selective ROCK2 inhibitor, blocks Rho-associated kinase 2 signaling, reduces STAT3-driven IL-17/IL-21, shifts Th17/Tfh toward Treg, and has antifibrotic effects via Rho/ROCK pathways. 2) Rituximab—an anti-CD20 chimeric monoclonal antibody, depletes B cells via complement/ADCC, lowering auto/alloantibody production and germinal center activity. Targeted cells/pathways: CD20+ B cells and germinal center B cells, T follicular helper cells, Th17 cells, STAT3 signaling, ROCK2/Rho pathways mediating inflammation and fibrosis in cGVHD.