About this trial
This is an interventional phase IV clinical study which is single-arm study for assessing the safety of belumosudil in Indian patients who are12 years and older.
Study details include:
* The study duration will be up to 12 months per participant. * The treatment duration will be up to 24 weeks. * The number of visits will be 7.
Eligibility criteria
Qualifiers
Male or female patients at least 12 years of age inclusive, at the time of signing the informed consent
Participants who had an allogeneic hematopoietic cell transplantation (HCT)
Previously received at least 2 prior lines of systemic therapy for cGVHD
Received glucocorticoid therapy with a stable dose over the 2 weeks prior to screening
Disqualifiers
Absolute neutrophil count ≤1.5 X 109/L
Platelet count ≤ 50 X 109/L
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 3 X upper limit of normal (ULN) (>5 × ULN if due to cGVHD)
Total bilirubin ≥ 1.5 X ULN
Trial design
Treatments tested in this trial
- Belumosudil