Status:
COMPLETED
Extended Treatment and Follow-up of Subjects Treated With Belumosudil in Study KD025-208 or Study KD025-213
Lead Sponsor:
Kadmon, a Sanofi Company
Conditions:
Chronic Graft-versus-host-disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Extended Treatment and Follow-up of Subjects Treated with Belumosudil in Study KD025-208 or Study KD025-213
Detailed Description
This is a Phase 2, open-label, long-term treatment and follow-up study in subjects with cGVHD who have been previously treated with belumosudil in Study KD025-208 or Study KD025-213. Subjects will not...
Eligibility Criteria
Inclusion
- Subjects must have been treated with belumosudil for at least 1 of the following:
- Actively receiving belumosudil on Study KD025-208 or Study KD025-213
- Is in Long-term Follow-up (LTFU) on Study KD025-208 or Study KD025-213. Long-term Follow-up will be defined as the period after ending treatment with belumosudil and until a FFS event occurs.
- Adult enrolled in the Companion Study under KD025-213 Amendment 2 (01 June 2020) and has received at least 6 months of treatment of belumosudil or is in LTFU
Exclusion
- Female subject who is pregnant or breastfeeding
- Subject considered unlikely to adhere to treatment and/or follow protocol in the opinion of the Investigator
Key Trial Info
Start Date :
February 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 6 2024
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT05305989
Start Date
February 23 2022
End Date
June 6 2024
Last Update
May 2 2025
Active Locations (8)
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1
City of Hope Site Number : 050
Duarte, California, United States, 91010
2
Stanford Cancer Center Site Number : 108
Stanford, California, United States, 94305
3
Washington University School of Medicine Site Number : 125
St Louis, Missouri, United States, 63110
4
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center Site Number : 132
Pittsburgh, Pennsylvania, United States, 15232