This phase II trial compares the effect of belumosudil to a placebo in treating patients with chronic graft versus host disease. Chronic graft versus host disease remains a major complication of stem cell transplantation and can involve multiple organ systems. Belumosudil is a ROCK2 selective inhibitor that works to reduce the immune system response causing the chronic graft versus host disease. Giving belumosudil may better treat patients with chronic graft versus host disease and prevent the need for starting additional immune suppressive medications.
At least one diagnostic or distinctive cGVHD manifestation(s), with a clinical diagnosis of cGVHD,but patients do not need to meet National Institute of Health (NIH) criteria for cGVHD
If eye involvement only, cGVHD must be confirmed on exam by an ophthalmologist or optometrist
No new immune suppressive therapy added within preceding 2 weeks prior to study enrollment for any indication
Continuation of agents previously given as either GVHD prophylaxis or acute/late acute GVHD therapy are permitted. Modification of dose of these agents for targeting of therapeutic drug levels is permitted, as are decreases in existing prednisone or prednisone equivalent dose based on routine clinical tapering practices. Increases in prednisone or prednisone equivalents are not allowed in the 2 weeks prior to enrollment
Any systemic immune suppressive treatment for cGVHD (topical or local therapies are allowed)
Plan to start systemic immune suppressive therapy for cGVHD or increase steroid dose within 14 days after planned start of study medication
0.25 mg/kg/day or higher prednisone or prednisone equivalent dose at time of screening
History of non-compliance that in the investigator's opinion would interfere with study participation
Fred Hutchinson Cancer Center
Lead sponsor
Sanofi
Collaborator