Back to search results

Phase I/II Study for Newly-Diagnosed TP53-Mutated AML

This study is testing a combination of two drugs, Bortezomib and CPX-351, for people newly diagnosed with acute myeloid leukemia (AML) that has a specific genetic change called a TP53 mutation. Researchers want to see how safe and effective this combination treatment is. To join, you must be an adult (18 or older) and have not received other chemotherapy for AML. The study will look at how many participants have a complete response (when signs of cancer disappear) over two years and will also determine the highest safe dose of the treatment. The study plans to enroll 32 participants.

Study design
This is a Phase I/II study, meaning it will first look at safety and then at how well the treatment works. It is an interventional study, and 32 participants are planned.
What's involved
Bortezomib will be given under the skin on days 1, 4, 8, and 11. CPX-351 will be given into a vein on days 1, 3, and 5.
Compensation
Not stated in the trial record.
Follow-up
The study will measure complete response at 2 years and determine the maximum tolerated dose at 1 year. Other outcomes like overall survival and disease-free survival will be tracked at 1 and 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07008638

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)

Recruiting
PHASE1Ages 18+InterventionalTreatment
Masonic Cancer Center, University of Minnesota
~32 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:BortezomibCPX-351

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants with Complete Response
Measured over 2 years
+1 more outcome measured

Conditions

Acute Myeloid Leukemia
TP53

Explore related trials

Acute Myeloid LeukemiaTP53 Gene

Where it's being run

1 sites across 1 states
Minnesota1

Who to contact

Joseph Norton, DO
[email protected]
(612) 626-3107
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Percentage of Participants with Complete Response2 years

    To evaluate the CR rate of bortezomib + CPX-351 for the treatment of TP53m AML.

  • Determine Maximum Tolerated Dose1 year