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NOT YET RECRUITING
NCT07643025
PHASE2

Belumosudil With Ruxolitnib as Second Line Therapy for Chronic Graft Versus Host Disease (cGvHD) After Steroid Failure

Sponsor: Dennis Kim

View on ClinicalTrials.gov

Summary

Chronic graft-versus-host disease (cGvHD) is a serious condition that can happen after a stem cell or bone marrow transplant. The donor's immune cells attack the patient's body, causing inflammation, pain, and damage to organs like the skin, liver, or lungs. For patients with moderate to severe cGvHD who don't improve with or can't tolerate standard front line therapy with steroids, there's a significant unmet need. Steroid-refractory cGvHD is hard to treat, with limited effective options, often leading to ongoing symptoms and reduced quality of life. This Phase II study tests a new treatment combining two oral drugs, ruxolitinib and belumosudil, for these patients. Both drugs have helped cGvHD individually, but this trial explores if they work better together. For the first 28 days (Cycle 1), patients take ruxolitinib (10 mg twice daily). From Cycle 2, they add belumosudil (200 mg once or twice daily, depending on other medications) for 48 weeks (12 cycles) unless their condition worsens or side effects become intolerable. Follow-up visits occur 30 days and 6 months after treatment ends to check health status. The study is non-randomized (all get the same treatment) and open-label (patients and doctors know the drugs used). It aims to see if this combination better controls cGvHD in patients where steroids failed. This could offer hope for better symptom management and improved quality of life for those with limited treatment options.

Official title: A Phase 2 Study of Belumosudil Combined With Ruxolitinib as Second Line Therapy to Treat Chronic Graft Versus Host Disease (cGvHD) After Steroid Failure (BELRUX)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

63

Start Date

2026-07

Completion Date

2030-07

Last Updated

2026-06-11

Healthy Volunteers

No

Conditions

Interventions

DRUG

Belumosudil

Patients receive ruxolitinib (10 mg twice daily) alone for one 28-day cycle, then add belumosudil (200 mg once or twice daily if on a PPI) from cycles 2-12 (48 weeks total), unless cGvHD progresses or side effects become intolerable.

DRUG

Ruxolitinib

Patients receive ruxolitinib (10 mg twice daily) alone for one 28-day cycle, then add belumosudil (200 mg once or twice daily if on a PPI) from cycles 2-12 (48 weeks total), unless cGvHD progresses or side effects become intolerable.

Locations (1)

University Health Network

Toronto, Ontario, Canada