Bortezomib combined with CPX-351 for newly diagnosed TP53‑mutated acute myeloid leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase I/II trial gives adults with newly diagnosed TP53‑mutated AML a combination of bortezomib (a proteasome inhibitor) and CPX‑351 (liposomal daunorubicin and cytarabine) to define safety and look for early signs of benefit. Phase I uses dose escalation to determine tolerability and a recommended dose, while Phase II measures preliminary efficacy outcomes such as complete remission, minimal residual disease status, and overall response rate. Secondary endpoints include rate of proceeding to allogeneic hematopoietic cell transplant, treatment‑related mortality, overall survival, and disease‑free survival at one and two years. All outcome assessments are performed alongside standard‑of‑care AML management at the sponsor site.

Why it matters

Who can join: the full rules

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
* 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

Where it's running

• Masonic Cancer Center
  Minneapolis, Minnesota, United States Recruiting

Study contacts

• Study coordinator: Joseph Norton, DO
• Email: norto491@umn.edu
• Phone: (612) 626-3107

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.