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)

Launched by MASONIC CANCER CENTER, UNIVERSITY OF MINNESOTA · Jun 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for adults with a specific type of leukemia called acute myeloid leukemia (AML) that has a mutation in a gene known as TP53. The researchers want to find out if combining two medications—bortezomib, a proteasome inhibitor, and CPX-351, a special formulation of two chemotherapy drugs—can help improve safety and effectiveness for patients who are newly diagnosed with this condition. The goal is to see how well the treatment works, how safe it is, and how it affects patients' chances of going into remission and living longer without their disease.

To participate in this trial, individuals must be adults aged 18 or older who have not received any chemotherapy for their leukemia. They should also meet certain health criteria, such as having adequate kidney and heart function. Participants will receive the study treatment and be monitored closely to assess their response and any side effects. It's important to note that the trial is not currently recruiting participants, so interested individuals will need to wait until it begins. Additionally, those who are pregnant, breastfeeding, or have certain serious health conditions may not be eligible to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult (age ≥ 18 years at time of consent)
• • Have not received any systemic chemotherapy for the treatment of AML. Use of hydroxyurea and leukapheresis to control excess peripheral blasts is permissible. WBC \< 25,000 to initiate bortezomib, must reach this threshold by day 7 of CPX-351.
• • Karnofsky performance status (KPS) ≥ 70
• • Adequate renal, hepatic and cardiac function defined as
• • Renal: An estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2
• • Hepatic: AST and ALT ≤3 x ULN, ALP ≤2.5 x ULN, and total bilirubin ≤1.5 x ULN. (exception for Gilbert's syndrome or leukemic infiltration of liver)
• • Cardiac: New York Heart Association (NYHA) Class I or II, left ventricular ejection fraction \> 50% by echocardiogram, MUGA or cardiac MRI
• • Sexually active couples of childbearing potential must agree to use effective contraception or abstinence during treatment and for at least 7 months after the final dose of study drug
• • Provides voluntary written consent before the performance of any study related activities not part of standard of care.
• Exclusion Criteria:
• • Received systemic chemotherapy for the treatment of AML
• • Bi-phenotypic acute leukemia or mixed lineage leukemia, acute promyelocytic leukemia
• • Active central nervous system malignancy or symptoms of CNS involvement
• • Symptomatic extramedullary disease
• • Known history of uncontrolled HIV or active hepatitis B or active hepatitis C infection
• • Has any of the following cardiac abnormalities
• • Symptomatic congestive heart failure
• • Myocardial infarction less than or equal to 6 months prior to enrollment
• • Unstable angina pectoris
• • Serious uncontrolled cardiac arrhythmia
• • Concomitant malignancies or previous malignancies with less than a 1-year disease free interval at the time of signing consent. Potential participants with adequately resected basal or squamous cell carcinoma of the skin, or adequately resected carcinoma in situ (e.g., cervix) may enroll irrespective of the time of diagnosis
• • Participants for whom administration of CPX-351 would exceed their lifetime cumulative daunorubicin exposure limit of 550 mg/m2 (or 400 mg/m2 in patients with prior chest radiation) or equivalent anthracycline dose.
• • Pregnant or breastfeeding, or planning pregnancy within 3 months after the treatment completion