V-FAST: a phase 1b master trial to investigate CPX-351 combined with targeted agents in adults with newly diagnosed AML.

ABSTRACT: Preclinical data suggest CPX-351, approved for patients with newly diagnosed therapy-related acute myeloid leukemia (AML) or AML with myelodysplasia-related changes, may exhibit synergy with targeted agents, suggesting a rationale for combining targeted agents with CPX-351 as a chemotherapy backbone. The V-FAST (Vyxeos - First Phase ASsessment With Targeted Agents) phase 1b trial evaluated CPX-351 with the targeted agents venetoclax (arm A), midostaurin (arm B), and enasidenib (arm C) in adults with newly diagnosed AML fit for intensive chemotherapy. The dose exploration phase used a 3+3 design to determine the recommended phase 2 dose (RP2D) for each combination. The expansion phase enrolled additional patients to confirm the RP2D. Primary end points were the RP2D and safety. Secondary en

SUBMITTER: Pullarkat VA 

PROVIDER: S-EPMC12418821 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature