Relapsed or Refractory B-Cell Malignancies
Conditions
Brief summary
Number of patients with dose-limiting toxicities (Part 1a), Number of patients with treatment-emergent adverse events (Part 1a, part 1b), Number of patients with treatment-related adverse events (Part 1a, part 1b), Number of patients with serious adverse events (Part 1a, part 1b)
Detailed description
Overall response rate (ORR) as assessed by the investigator (Part 1a, part 1b), Duration of response (DOR) (Part 1a, part 1b), Time-to-response (TTR) (Part 1a, part 1b), Derived PK parameters of BGB-16673 (Part 1a), Plasma concentration data (Part 1a, part 1b), Number of patients with complete response/complete response with incomplete count recovery (CR/CRi) who achieve uMRD status with < 10^(-4) sensitivity in peripheral blood and/or bone marrow (Part 1b, sub-study 1 only), Derived PK parameters of sonrotoclax (Part 1a, sub-study 1 only)
Interventions
Sponsors
BeOne Medicines AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with dose-limiting toxicities (Part 1a), Number of patients with treatment-emergent adverse events (Part 1a, part 1b), Number of patients with treatment-related adverse events (Part 1a, part 1b), Number of patients with serious adverse events (Part 1a, part 1b) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR) as assessed by the investigator (Part 1a, part 1b), Duration of response (DOR) (Part 1a, part 1b), Time-to-response (TTR) (Part 1a, part 1b), Derived PK parameters of BGB-16673 (Part 1a), Plasma concentration data (Part 1a, part 1b), Number of patients with complete response/complete response with incomplete count recovery (CR/CRi) who achieve uMRD status with < 10^(-4) sensitivity in peripheral blood and/or bone marrow (Part 1b, sub-study 1 only), Derived PK parameters of sonrotoclax (Part 1a, sub-study 1 only) | — |
Countries
Germany, Italy, Poland
Outcome results
None listed