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Belumosudil With Ruxolitnib as Third Line Therapy for Chronic Graft Versus Host Disease (cGvHD)

Study acronym: BELRUX
StatusNot Yet Recruiting
PhasePhase 2
SponsorDennis Kim
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Jul 2029 → Nov 2029
Primary endpoint reworded 1 of 1 changed
Enrollment reduced 16% 63 → 53 participants
See other at-risk trials from Dennis Kim

Record History

  1. Primary endpoint(s) modified Start date: Jul 2026 to Nov 2026 · Primary completion pushed from Jul 2029 to Nov 2029 · Enrollment reduced: 63 → 53 participants · 4 more Show 7 more changesShow less
    • Start date: Jul 2026 to Nov 2026
    • Primary completion pushed from Jul 2029 to Nov 2029
    • Enrollment reduced: 63 → 53 participants
    • Completion pushed from Jul 2030 to Nov 2030
    • Eligibility criteria expanded, about 140 words
    • Secondary endpoint revised
    • Study title shortened, about 3 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Dennis Kim
1 trial monitored
See 1 trial at risk
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. Patients will begin on ruxolitinib (10 mg twice daily) and will continue for up to 48 weeks. Upon ruxolitinib treatment failure, patients will add belumosudil (200 mg once or twice daily, depending on other medications) in addition to ruxolitinib for 48 weeks (12 cycles) unless their condition worsens or side effects become intolerable. Follow-up visits occur 28 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.
Trial Details
NCT Number NCT07643025
Lead Sponsor Dennis Kim
Collaborators: Sanofi
Conditions cGVHD
Enrollment 53 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov