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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06846671 | A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors | PHASE3 | RECRUITING | 250 | — | — | Apr 10, 2025 | Feb 14, 2030 | May 29, 2026 | 117 | United States, Argentina +12 |
PFS is defined as time from the date of randomization to the date of first disease progression or death, whichever occurs first, as determined by IRC using modified 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for participants with chronic lymphocytic leukemia (CLL) and Lugano classification for participants with small lymphocytic lymphoma (SLL).
| Arm | Type | Description |
|---|---|---|
| Arm A: BGB-16673 monotherapy | EXPERIMENTAL | Participants will receive BGB-16673 once daily until any of the treatment discontinuation criteria are met |
| Arm B: Investigator's Choice | ACTIVE_COMPARATOR | Participants will receive investigator's choice of idelalisib plus rituximab for CLL only or bendamustine plus rituximab, or venetoclax plus rituximab retreatment. |
| Name | Type | Description |
|---|---|---|
| BGB-16673 | DRUG | Administered orally |
| Bendamustine | DRUG | Administered intravenously |
| Idelalisib | DRUG | Administered orally |
| Rituximab | DRUG | Administered intravenously |
| Venetoclax | DRUG | Administered orally |
Inclusion Criteria: 1. Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria. 2. Previously received treatment for CLL/SLL with both a BTKi and a BCL2i. 3. Participants with SLL must have measurable disease by c...