Belumosudil + Ruxolitinib for Graft-versus-Host Disease

(BELRUX Trial)

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.