Phase IBII Study of CPX-351 as Maintenance Treatment for Adults with Acute Myeloid Leukemia in Remission For Patients Not Eligible for Bone Marrow Transplantation

What this Trial Is About

Researchers are evaluating CPX-351 as a maintenance therapy for patients with acute myeloid leukemia AML who are in remission but ineligible for bone marrow transplantation. This phase IBII study uses a 33 dose de-escalation design to find the maximum tolerated dose of CPX-351 given every 28 days. The goal is to prevent relapse in AML patients who have completed induction treatment and achieved remission. The study compares two dosing schedules Dose Level 1 administers CPX-351 intravenously on Day 1 and Day 3 of a 28-day cycle for 6 cycles, while Dose Level -1 gives a reduced dose on Day 1 only of each cycle for 6 cycles. Participants will remain on maintenance treatment as long as they stay in complete remission. The maximum tolerated dose determined in the first phase will be used for the phase II expansion. Participants will undergo regular treatment cycles with clinical monitoring for adverse events and survival outcomes. Researchers will assess safety by tracking treatment-related side effects during the 6 treatment cycles. They will also measure overall survival, event-free survival, and relapse-free survival for up to one year after treatment ends. This study lasts throughout the treatment cycles and includes long-term follow-up to evaluate the therapys impact.

Phase IB/II of CPX-351 for Relapse Prevention in AML