The objective of this phase II study is to evaluate the efficacy and safety of BR101801 in patients with peripheral T-cell lymphoma(PTCL).
This phase II study will evaluate the efficacy and safety of single-dose BR101801 once daily in patients with peripheral T-cell lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Patients will receive 200mg capsules (100mg+100mg)
Confirmed Objective Response Rate (ORR) (CR + PR) assessed by a blinded independent reviewer at the central lab according to the 2014 Lugano criteria
Time frame: Up to 2 years
Objective Response Rate (ORR) (CR + PR) assessed by a blinded independent reviewer at the central lab according to the 2014 Lugano criteria
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: Up to 2 years
Disease Control Rate (DCR)
Time frame: Up to 2 years
Duration of Response (DOR)
Time frame: Up to 2 years
Progression-free Survival (PFS)
Time frame: Up to 2 years
Time to Tumor Progression (TTP)
Time frame: Up to 2 years
Quality of life assessment Using the EQ-5D-5L assessment
European quality of life 5 dimensions questionnaire. The values is 0 to 1, whereby 0 indicates death and 1 perfect health
Time frame: Every 2 cycles for up to 24 months (each cycle is 28 days)
Quality of life assessment Using EORTC QLQ-C30 assessment
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, EORTC QLQ-C30). All of the scales and single-item measures range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
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Time frame: Every 2 cycles for up to 24 months (each cycle is 28 days)
Plasma Concentration of BR101801 (Bosmolisib)
Blood samples were taken for the analyses of BR101801 in plasma at designated time points.
Time frame: Cycle 2 Day 1 and Day 1 of Cycle 3 (each cycle is 28 days)
Adverse events
Time frame: Approximately 24 months after a consent to the participation