Table 2 Key clinical trials of approved BCL-2 inhibitors for the treatment of CLL
From: Current and future treatment strategies in chronic lymphocytic leukemia
| Agent | Trial name | Trial design and patients | Outcomes | Citation |
|---|---|---|---|---|
| Venetoclax (second-line or later monotherapy) | NCT01889186 | Phase 2 single-arm study of the safety and efficacy of venetoclax in patients with del(17p) relapsed or refractory CLL |
ORR: 12.1-month median follow-up, 79.4%; final, 77% 24-month PFS: 54% SAEs: 12.1-month median follow-up, 55%; final, 58% | [49, 50] |
| Venetoclax (first-line combination therapy) | CLL14 (NCT02242942) | Phase 3 study of the efficacy and safety of venetoclax plus obinutuzumab versus chlorambucil plus obinutuzumab in treatment-naïve patients with CLL who have coexisting conditions |
Venetoclax plus obinutuzumab versus chlorambucil plus obinutuzumab: 24-month PFS: 88.2% versus 64.1% Results were similar for TP53 deletion/mutation or unmutated IGHV Grade ≥ 3 AEs: 78.8% versus 76.6% | [51] |
| Venetoclax (second-line or greater combination therapy) | MURANO (NCT02005471) | Phase 3 study of the efficacy and safety of venetoclax plus rituximab versus bendamustine plus rituximab in patients with relapsed or refractory CLL/SLL |
Venetoclax plus rituximab versus bendamustine plus rituximab: 24-month PFS: 84.9% versus 36.3% Results were similar for TP53 deletion or unmutated IGHV Grade ≥ 3 AEs: 82.0% versus 70.2% | [50] |