NCT07135973
A Study to Investigate Safety of Belumosudil in Participants Aged 12 Years and Above, With Chronic Graft-versus-host Disease (cGVHD)
Track this trial
Free. We email you which fields changed when ClinicalTrials.gov updates this record.
Record History
All 6 versions: 6 with changes below. See every version on ClinicalTrials.gov ↗
- Minor Start date pushed from Oct 30, 2026 to Nov 20, 2026
- Notable Start date: Aug 10, 2026 to Oct 30, 2026
- Eligibility criteria expanded, about 14 words
- Secondary endpoints revised (12)
- Notable Start date: Apr 15, 2026 to Aug 10, 2026v4
- Notable Start date: Nov 28, 2025 to Apr 15, 2026
- Eligibility criteria expanded, about 20 words
- Notable Start date: Aug 29, 2025 to Nov 28, 2025v2
- Study First Submitted
- Notable: the plan changed
- Minor: routine updates
Endpoints
Primary
Drug related Grade ≥ 3 treatment emergent adverse events (TEAE)
Timeframe: From baseline to 24 weeks
Secondary (12)
Best overall Response (BoR)
Duration of Response (DOR)
Time to Response (TTR)
Response by organ system (including GSR)
Time taken for New Treatment (TTNT) or death
Show 7 moreShow less
Failure-free survival (FFS)
Overall survival (OS)
Change in Corticosteroid dose.
Change in CNI dose
Symptomatic improvement from baseline during treatment based on Lee Symptom Scale
Pulmonary Function Test (PFT)
Number of participants with treatment-emergent adverse events [TEAEs], serious TEAEs, and adverse events of special interest (AESIs)
Arms and interventions
belumosudilExperimental
200 mg taken orally once daily with food for 24 weeks
Drugs: Belumosudil