Clinical Trial

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

Recruiting Phase 1/2
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Summary
This is a phase IB/II study with a 3+3 dose de-escalation study design. Patients will continue maintenance treatment with CPX-351 for 6 cycles on D1 and D3, as long as patient remains in CR. The dose de-escalation will be one dose given on D1 only, every 28 days pending toxicity. The maximum tolerated dose will be used for the phase II expansion portion of the study.
Protocol Amendment History 17 amendments
This ClinicalTrials.gov record has been amended 17 times since 2021-07-26; most recent amendment 2026-03-19.
Status change: Not Yet Recruiting → Recruiting 2022-01-11
Trial Details
NCT Number NCT04990102
Lead Sponsor Georgetown University
Collaborators: Jazz Pharmaceuticals, National Heart, Lung, and Blood Institute (NHLBI)
Conditions Acute Myeloid Leukemia (AML) in Remission
Enrollment 24 participants
Start Date 2023-05-22
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-03-23