Phase II trial of CPX-351 in patients with acute myeloid leukemia at high risk for induction mortality.

ABSTRACT: CPX-351 is a liposomal formulation of cytarabine/daunorubicin with a 5:1 fixed molar ratio. We investigated the safety and efficacy of escalating doses of CPX-351 in patients with acute myeloid leukemia (AML) at high risk of induction mortality with standard chemotherapy determined through assessment of leukemia and patient-related risk factors for intensive chemotherapy in an open-label, phase II trial. Patients were randomized to receive 50 or 75 units/m² on days 1, 3, and 5. Once safety was established, a 100 units/m² arm was opened. Fifty-six patients were enrolled, 16, 24, and 16 in the 50, 75, and 100 units/m² arms, respectively. The composite complete remission rate (complete remission + complete remission with incomplete blood count recovery) was lo

SUBMITTER: Issa GC 

PROVIDER: S-EPMC11450557 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature