A Trial of CPX-351 Lower Intensity Therapy (LIT) Plus Venetoclax as First Line Treatment for Subjects With AML

Summary

Study CPX351-103 is an open-label, multicenter, phase 1b, safety and PK study to determine the MTD of the combination of CPX 351 and venetoclax when administered to subjects with newly diagnosed AML who are unfit for intensive chemotherapy (ICT) and to determine the recommended phase 2 dose (RP2D) for the Expansion Phase. This study will comprise 2 phases: a Dose Exploration Phase (Part 1) and an Expansion Phase (Part 2), in which all subjects will receive a combination of CPX-351 and venetoclax.

Timeline

Start

2019-10-15

Primary completion

2022-04-26

Completion

2022-09-24

Publications

• Uy GL, Pullarkat V, Baratam P, Stuart RK, Walter RB, Winer ES, Wang Q, Faderl S, Chakravarthy D, Menno D, Cheung RS, Lin TL. Lower-intensity CPX-351 plus venetoclax induction for adults with newly diagnosed AML unfit for intensive chemotherapy. Blood Adv. 2024 Dec 24;8(24):6248-6256. doi: 10.1182/bloodadvances.2024013687.

Drugs

Indications