This is an open-label, Phase 2 study designed to evaluate the safety and efficacy of belumosudil and rituximab as primary treatment of cGVHD.
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#
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.
Single group
Belumosudil
Drug200mg PO QD x 24 cycles (28-day cycle)
Rituximab
Drug375mg/m2 IV Q1 week x 4 weeks, then Q3 months x4 doses
Number of patients who achieve partial and complete responses after treatment
Length of time patients remain on corticosteroid treatment
Number of patients who had treatment-related adverse events using CTCAE v5
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Northside Hospital, Inc.
Lead sponsor
Sanofi
Collaborator
