Status:
RECRUITING
Belumosudil and Rituximab for Primary Treatment of Chronic Graft-Versus-Host-Disease
Lead Sponsor:
Northside Hospital, Inc.
Collaborating Sponsors:
Sanofi
Conditions:
Chronic Graft Versus Host Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 Criteria
Inclusion
- 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#
Exclusion
- Late persistent or recurrent aGVHD
- Active uncontrolled infection
- History of HIV infection
- Active HBV or HCV infection. Subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative PCR result before enrollment. Those who are PCR positive will be excluded.
- Calculated CrCl \<30mL/min
- AST and/or ALT \>5x ULN or direct bilirubin \>3x ULN
- Cardiac ejection fraction \<40% or history of uncontrolled cardiac arrhythmias
- Has received more than one allogeneic transplant prior to the occurrence of cGVHD
Key Trial Info
Start Date :
January 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06046248
Start Date
January 29 2024
End Date
December 31 2027
Last Update
October 30 2025
Active Locations (1)
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1
Northside Hospital
Atlanta, Georgia, United States, 30342