Study on Proteasome Inhibitor and CPX-351 for Treating Newly-Diagnosed TP53-Mutated Acute Myeloid Leukemia (AML)

Sponsor: Masonic Cancer Center, University of Minnesota

Sponsor score: 40

ClinicalTrials ID:NCT07008638

Provider View

This clinical trial is testing a new treatment combination of a proteasome inhibitor and CPX-351 for adults with newly-diagnosed TP53-mutated acute myeloid leukemia (AML). The study aims to determine the safety and effectiveness of this treatment.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new treatment combining a proteasome inhibitor (bortezomib) with CPX-351 (a combination of daunorubicin and cytarabine) for adults with newly-diagnosed TP53-mutated acute myeloid leukemia (AML). The study will first focus on assessing the safety and tolerability of the treatment (Phase I) and then evaluate its effectiveness in treating the disease (Phase II). Researchers will also look at various outcomes, such as the rate of complete remission, overall response, survival rates, and the possibility of undergoing a stem cell transplant. The goal is to see if this treatment can safely and effectively improve outcomes for patients with this type of leukemia.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 years or older.
  • Have not received any systemic chemotherapy for AML, but can use hydroxyurea or leukapheresis to control high white blood cell counts.
  • Must have a white blood cell count below 25,000 to start bortezomib, reaching this level by day 7 of CPX-351 treatment.
  • Have a Karnofsky performance status of 70 or higher, indicating they can carry out normal activities with some effort.
  • Have adequate kidney, liver, and heart function as determined by specific medical tests.
  • Sexually active individuals must agree to use effective birth control or abstain from sex during treatment and for at least 7 months after the last dose.
  • Must provide written consent to participate in the study.

Exclusion Criteria

  • Have received systemic chemotherapy for AML.
  • Have a type of leukemia that is bi-phenotypic, mixed lineage, or acute promyelocytic.
  • Have active cancer in the central nervous system or symptoms of such involvement.
  • Have symptomatic disease outside the bone marrow.
  • Have uncontrolled HIV or active hepatitis B or C infections.
  • Have serious heart conditions, such as heart failure, recent heart attack, unstable chest pain, or uncontrolled heart rhythm problems.
  • Have other cancers or a history of cancer with less than a one-year disease-free period, except for certain skin cancers or carcinoma in situ that have been adequately treated.
  • Would exceed the safe lifetime dose of daunorubicin with CPX-351 treatment.
  • Are pregnant, breastfeeding, or planning to become pregnant within 3 months after completing treatment.

Locations

FACILITYZIPCITYSTATE
Masonic Cancer Center55455MinneapolisMinnesota

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