A Phase 2 Trial of CPX-351 Combined With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia.

ABSTRACT: Outcomes in patients with relapsed/refractory (RR) AML are poor. We sought to investigate if CPX-531 in combination with venetoclax (CPX + VEN) was tolerable and effective in RR AML. This was a single institution phase 1b/2 trial of CPX + VEN. Patients aged ≥ 18 years with RR AML who were fit for intensive chemotherapy were eligible. Prior venetoclax exposure was allowed. The phase 1b portion followed a 3 + 3 design to identify the recommended phase 2 dose (RP2D) for the expansion cohort. At the starting dose level of -1, prolonged myelosuppression was observed, leading to dose level -2 (CPX-351 dosed at daunorubicin 44 mg/m² on days 1,3, and 5 and venetoclax 300 mg days 2-8) being chosen as the RP2D. Thirty three patients with a median age of 58 years (range, 26-72) were treate

SUBMITTER: Kadia TM 

PROVIDER: S-EPMC12510378 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature