NCT05996627

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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. After completion of study treatment, patients are followed up at 30 days, at 60 days if 12 cycles are completed, and then up to 18 months.

Conditions

• Chronic Graft Versus Host Disease

Interventions

Type	Name	Description
DRUG	Belumosudil	Given PO
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
OTHER	Electronic Health Record Review	Ancillary studies
DRUG	Placebo Administration	Given PO

Timeline

• Start date: 2023-12-06
• Primary completion: 2028-04-30
• Completion: 2028-11-30
• First posted: 2023-08-18
• Last updated: 2026-02-17

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study