Randomized Phase II Study of Belumosudil vs. Placebo for Preemptive Treatment of Chronic Graft Versus Host Disease
Fred Hutchinson Cancer Center
Summary
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.
Description
OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive belumosudil orally (PO) daily (QD) or twice daily (BID) if taken with strong CYP3A inducers or proton pump inhibitors for days 1 through 28 of each cycle. Cycles repeat every 28 days for a total of 11 cycles, followed by one cycle of tapering prior to discontinuation, in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive a placebo PO QD or BID if taken with strong CYP3A inducers or proton pump inhibitors for days 1 through 28 of each cycle. Cycles repeat every 28 days for a total of 11…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 therapeuti…
Interventions
- DrugBelumosudil
Given PO
- ProcedureBiospecimen Collection
Undergo blood sample collection
- OtherElectronic Health Record Review
Ancillary studies
- DrugPlacebo Administration
Given PO
Locations (4)
- Moffitt Cancer CenterTampa, Florida
- Dana-Farber Cancer InstituteBoston, Massachusetts
- Memorial Sloan Kettering Cancer CenterNew York, New York
- Fred Hutch/University of Washington Cancer ConsortiumSeattle, Washington