Phase II Trial of Belumosudil and Rituximab for the Primary Treatment of Extensive Chronic Graft-versus-host Disease
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is an open-label, Phase 2 study designed to evaluate the safety and efficacy of belumosudil and rituximab as primary treatment of cGVHD.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• First episode of systemic immunosuppression-requiring cGVHD, defined as classic cGVHD by the NIH consensus criteria (without features or characteristics of aGVHD)
• Previously untreated, defined by having received \<10 days of corticosteroids or alternative systemic immunosuppressive agent started specifically for a new diagnosis of cGVHD
• KPS \>/= 70%
• Adequate hematologic function independent of platelet transfusion and G-CSF for at least 7 days prior to study entry: ANC \>750 cells/mm3; Platelets \>30,000 cells/mm#
Locations
United States
Georgia
Northside Hospital
RECRUITING
Atlanta
Contact Information
Primary
Scott Solomon, MD
ssolomon@bmtga.com
404-255-1930
Backup
Caitlin Guzowski, MBA, MHA
caitlin.guzowski@northside.com
404-851-8523
Time Frame
Start Date: 2024-01-29
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 25
Treatments
Experimental: Belumosudil Plus Rituximab
Belumosudil plus Rituximab
Related Therapeutic Areas
Sponsors
Leads: Northside Hospital, Inc.
Collaborators: Sanofi