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Belumosudil for the Pre-emptive Treatment of Patients With Chronic Graft Versus Host Disease

Chronic Graft Versus Host Disease Clinical Trial

Official title:
Randomized Phase II Study of Belumosudil vs. Placebo for Preemptive Treatment of Chronic Graft Versus Host Disease

Clinical Trial 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.

Clinical Trial 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 cycles, followed by one cycle of tapering prior to discontinuation, in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection on study. Patients follow up after completion of study medication at 30 days, and at 60 days if 12 cycles are completed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05996627
Study type Interventional
Source Fred Hutchinson Cancer Center
Contact Chloe Te
Phone 206-667-4196
Email cte@fredhutch.org
Status Recruiting
Phase Phase 2
Start date December 6, 2023
Completion date December 31, 2027
View Details
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