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

Sponsor
Dennis Kim
Study ID
NCT07643025
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Belumosudil — DRUG
    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.
  • Ruxolitinib — DRUG
    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.

Study Details

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.

Key Dates

First listed
Jun 11, 2026
Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2029
Completion
Jul 31, 2030

Study Design

Enrollment
63 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Combination therapy with two oral agents (belumosudil, ruxolitinib)
    Ruxolitinib monotherapy (4 weeks), then combination therapy with belumosudil (48 weeks), 52 weeks total, unless cGvHD progresses or side effects become intolerable.

Primary Outcome Measure

Efficacy will be assessed using overall response rate (ORR) as per the NIH cGvHD Consensus Response Criteria at 24 weeks of combination treatment. Tolerability and safety will be assessed by the incidence and severity of adverse events (AEs) [ Time Frame: Enrollment to 24 and 48 weeks after combination therapy. ]

Central Contacts

Related Studies