RecruitingPhase 1Phase 2NCT07008638

Phase I/II Clinical Trial of Proteasome Inhibitor in Combination With CPX-351 for the Treatment of Newly-Diagnosed TP53-mutated Acute Myeloid Leukemia (AML)

HM2024-29: Phase I/II Clinical Trial of Proteasome Inhibitor in Combination With CPX-351 for the Treatment of Newly-Diagnosed TP53-mutated Acute Myeloid Leukemia (AML)

Sponsor

Masonic Cancer Center, University of Minnesota

Enrollment

32 participants

Start Date

Jul 7, 2025

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia TP53

Summary

This is a Phase I/II study evaluating safety and efficacy of proteasome inhibitor (bortezomib) in combination with CPX-351 (liposomal daunorubicin and cytarabine) for the treatment of newly-diagnosed TP53-mutated acute myeloid leukemia (TP53m AML). The primary endpoint of the study is to define safety/tolerability (phase I) and preliminary efficacy profile (phase II) of the treatment. The secondary endpoints of interest are complete remission (CR) rate, detectable minimal residual disease (MRD) status, overall response rate (ORR), rate of allogeneic hematopoietic cell transplantation (allo-HCT), treatment-related mortality (TRM), overall survival (OS), achievement of complete remission anytime in 1 year, and disease-free survival (DFS) at 1 year and 2 years. All the patient outcomes assessments will be performed as part of standard-of-care AML management. The hypothesis is the combination of bortezomib and CPX-351 will have an acceptable safety profile in this patient population based on the data from previous studies. The treatment will attenuate Nuclear Factor kB pathway activation in these cells and eradicate TP53m leukemia stem cells (LSC) leading to increased response rate and survival in these patients.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase I/II study is testing whether adding a proteasome inhibitor (a drug that interferes with cancer cell breakdown processes) to CPX-351 (a combination chemotherapy) can improve outcomes for patients with newly diagnosed AML that has a TP53 mutation — a particularly difficult-to-treat form of the disease. **You may be eligible if...** - You are 18 years or older - You have newly diagnosed AML with a TP53 mutation and have not yet received chemotherapy for it - Your overall functional status is adequate (Karnofsky score ≥ 70) - Your heart, kidney, and liver function meet required levels (including LVEF > 50%) **You may NOT be eligible if...** - You have already received systemic chemotherapy for AML - You have a special type of leukemia (bi-phenotypic, mixed-lineage, or acute promyelocytic leukemia) - You have active CNS involvement (brain) - You have uncontrolled HIV, active hepatitis B or C - You have certain serious heart abnormalities 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

DRUGBortezomib

Bortezomib at assigned study dose in mg/m2 will be given subcutaneously on days 1, 4, 8, and 11

DRUGCPX-351

CPX-351 given intravenously on day 1, 3, and 5

Locations(1)

Masonic Cancer Center

Minneapolis, Minnesota, United States

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NCT07008638

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