Skip to main content

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]
  1. AE adverse event, BCL-2 B-cell lymphoma 2, CLL chronic lymphocytic lymphoma, IGHV, immunoglobulin heavy chain, ORR overall response rate, PFS progression-free survival, SAE serious adverse event, SLL small lymphocytic lymphoma