NCT06046248PHASE2Recruiting
Belumosudil and Rituximab for Primary Treatment of Chronic Graft-Versus-Host-Disease
Northside Hospital, Inc.
Start Date
1/29/2024
Completion Date
12/31/2027
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
Age Range: 18 years to No maximum
Inclusion Criteria:
* 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 Criteria:
* 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
Interventions
DRUG
Belumosudil
DRUG
Rituximab
Conditions
Chronic Graft Versus Host Disease
Locations
Northside Hospital
Atlanta, Georgia 30342
United States