The University of Virginia Comprehensive Cancer Center seeks participants ages 18 and over with a moderate or severe chronic graft versus host disease (cGVHD) that have not received any prior systemic treatment for cGVHD. The purpose of the study is to evaluate the efficacy and safety of belumosudil together with a corticosteroid (prednisone or prednisolone) versus placebo together with a corticosteroid (prednisone or prednisolone). Belumosudil is an oral medicine that regulates the immune reactions caused by the donor cells derived from the transplant. These immune reactions induce inflammation that damages normal tissues and promote scarring of the tissues to cause cGVHD. By regulating the immune reactions, belumosudil helps to decrease symptoms of cGVHD.
In this study, you will receive prednisone or prednisolone 1 mg/kg/day and either belumosudil 200 mg once a day or placebo once a day. Neither you nor your study doctor will know which arm of the study you are assigned to. This study may help doctors learn things that can help other people in the future.
If you are enrolled in treatment, you may need to have the following exams, tests, and procedures:
• ECG (Electrocardiogram. A simple, non-invasive test that records the electrical activity of the heart)
• Blood tests
• Lung function tests
• Health questionnaires
• Pregnancy test
• Physical exam
The study will be divided into 5 periods including a screening period up to 4 weeks, a treatment period, an end of treatment visit, at least 30 days safety follow-up after last dose of study treatment, and a long-term follow-up period.
Additional information found here: https://www.clinicaltrials.gov/study/NCT06143891?titles=ROCKnrol-1&rank…
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