Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05828589 | A Study of BGB-21447, a Bcl-2 Inhibitor, in Mature B-Cell Malignancies | PHASE1 | ACTIVE NOT_RECRUITING | 112 | — | — | Jun 20, 2023 | May 1, 2026 | Mar 12, 2026 | 28 | United States, Australia +2 |
Number of participants with dose limiting toxicities, as defined in the study protocol.
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) assessed and graded based upon the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0).
TLS will be determined via laboratory values and assessed by the investigator. In laboratory tumor lysis syndrome, 2 or more metabolic abnormalities must be present during the 24-hour period within 3 days before the start of study drug treatment or up to 7 days afterward. Clinical tumor lysis syndrome requires the presence of laboratory tumor lysis syndrome plus an increased creatinine level, seizures, cardiac dysrhythmia, or death.
| Arm | Type | Description |
|---|---|---|
| Part 1 (Cohort A1): Dose escalation in patients with B-cell non-Hodgkin lymphoma (NHL) | EXPERIMENTAL | Participants with R/R B-cell NHL (including diffuse large B-cell lymphoma \[DLBCL\], follicular lymphoma \[FL\], marginal zone lymphoma \[MZL\], transformed B-cell NHL (B-NHL), and Richter's transformation to DLBCL) will receive BGB-21447 once a day. |
| Part 1 (Cohort B): Dose escalation in R/R CLL/SLL participants with low tumor burden | EXPERIMENTAL | Participants with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) will receive BGB-21447 once a day. |
| Part 2 (Cohort A2.1): BGB-21447 Monotherapy Dose Optimization in R/R DLBCL | EXPERIMENTAL | Participants will receive BGB-21447 with two dose levels from Cohort A1 for further evaluation of safety and efficacy. |
| Part 2 (Cohort A2.2): BGB-21447 Monotherapy Dose Optimization in R/R FL or R/R MZL | EXPERIMENTAL | Participants will receive BGB-21447 with two dose levels from Cohort A1 for further evaluation of safety and efficacy. |
| Name | Type | Description |
|---|---|---|
| BGB-21447 | DRUG | BGB-21447 will be administered orally |
Inclusion Criteria 1. Confirmed diagnosis (per World Health Organization \[WHO\] guidelines, unless otherwise noted) of one of the following: Cohort A1 and Cohort A2: 1. R/R DLBCL (for Cohort A1 and Cohort A2.1) * High-grade B-cell lymphomas with translocations of MYC and Bcl-2 and/or...