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.
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
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
Single group
Belumosudil
DrugPharmaceutical form:Tablet-Route of administration:Oral
Drug related Grade ≥ 3 treatment emergent adverse events (TEAE)
Drug related Grade ≥ 3 treatment emergent adverse events (TEAE) during the treatment period (24 weeks)
Best overall Response (BoR)
Best overall Response (BoR), defined as the proportion of patients who achieved complete response (CR) or partial response (PR) according to the NIH Consensus Criteria.
Duration of Response (DOR)
Duration of Response (DOR) calculated from time of initial PR or CR until documented progression, death, or new systemic therapy.
Time to Response (TTR)
Response by organ system (including GSR)
This trial is not recruiting at the moment. You can still explore other options:
