Phase 12 Study of Belumosudil for Children Aged 1 to Under 18 Years with Moderate to Severe Chronic Graft Versus Host Disease

What this Trial Is About

Researchers are evaluating belumosudil, an oral medication, in children aged 1 to less than 18 years who have active moderate to severe chronic graft versus host disease cGVHD that has not responded to or has returned after at least two prior systemic treatments. This open-label, single-group Phase 12 study aims first to understand how the drug behaves in children aged 1 to less than 12 years and to find the right dose, then to assess safety and effectiveness in children up to 18 years. Participants will take belumosudil by mouth, either as an oral suspension or tablet, once daily with a meal, with possible dose adjustments for those taking certain other medications. The study includes an initial screening period of up to 4 weeks, followed by treatment continuing until significant disease progression, relapse, unacceptable side effects, or end of study. After stopping treatment, participants will have 30 days of safety follow-up and then long-term monitoring until death or study end. During the study, participants will have regular assessments including blood tests and monitoring for side effects. Researchers will measure drug levels in the body, overall response to treatment within 24 weeks, survival outcomes, and duration of response. The total study duration for each participant may be up to 3 years after the last participant joins, ensuring ongoing safety and treatment effect monitoring.

A Study of Belumosudil in Children With Chronic Graft Versus Host Disease (schoolROCK)