RecruitingPhase 1Phase 2NCT04990102

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

Phase IB/II of CPX-351 as Maintenance Therapy in AML Patients Ineligible for Bone Marrow Transplantation


Sponsor

Georgetown University

Enrollment

24 participants

Start Date

May 22, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a chemotherapy drug called CPX-351 to help prevent acute myeloid leukemia (AML — a cancer of the blood) from coming back in patients who have achieved remission but are not able to undergo a bone marrow transplant. **You may be eligible if...** - You are 18 or older with newly diagnosed AML that is now in complete remission - You received standard induction treatment and up to 6 cycles of consolidation therapy - You are not a candidate for a bone marrow transplant - Your heart function is adequate (ejection fraction at least 50%) - Your liver and kidney function are within acceptable ranges - You can start treatment within 3 months of your last documented remission **You may NOT be eligible if...** - You have had a prior bone marrow transplant - You have received high cumulative doses of certain heart-affecting chemotherapy drugs in the past - You have acute promyelocytic leukemia (a specific AML subtype) - You have active heart problems, Wilson's disease, or a copper metabolism disorder - You are pregnant or breastfeeding - You have active hepatitis B or C Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCPX-351

Daunorubicin 8.8mg/m2 + cytarabine 20mg/m2


Locations(3)

Georgetown Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, United States

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

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NCT04990102


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