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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Pharmaceutical 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)
Time frame: From baseline to 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.
Time frame: Baseline to end of study i.e. 12 months
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 frame: Baseline to end of study i.e. 12 months
Time to Response (TTR)
Time frame: Baseline to end of study i.e. 12 months
Response by organ system (including GSR)
Time frame: Baseline to end of study i.e. 12 months
Time taken for New Treatment (TTNT) or death
Time frame: Baseline to end of study i.e. 12 months
Failure-free survival (FFS)
Time frame: Baseline to end of study i.e. 12 months
Overall survival (OS)
Time frame: Baseline to end of study i.e. 12 months
Change in Corticosteroid dose.
Time frame: Baseline to end of study i.e. 12 months
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Change in CNI dose
Time frame: Baseline to end of study i.e. 12 months
Symptomatic improvement from baseline during treatment based on modified Lee Symptom Scale
defined as a ≥7-point reduction from baseline in total symptom score on a scale of 0 to 100 which measures the symptoms of chronic GVHD, with higher scores indicating worse symptoms
Time frame: Baseline to end of study i.e. 12 months
Pulmonary Function Test (PFT)
Total lung capacity, Residual volume, Forced expiratory volume, Tidal volume
Time frame: Baseline to end of study i.e. 12 months
Number of participants with treatment-emergent adverse events [TEAEs], serious TEAEs, and adverse events of special interest (AESIs)
Time frame: Baseline to end of study i.e. 12 months