Belumosudil and Rituximab for Primary Treatment of Chronic Graft-Versus-Host-Disease
Chronic Graft Versus Host Disease
About this trial
This is an interventional treatment trial for Chronic Graft Versus Host Disease
Eligibility Criteria
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
Sites / Locations
- Northside Hospital
Arms of the Study
Arm 1
Experimental
Belumosudil Plus Rituximab
Belumosudil plus Rituximab