Can a Two-Drug combo outsmart a deadly leukemia?

NCT ID NCT07008638

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This trial is testing whether adding bortezomib to standard chemotherapy (CPX-351) can improve outcomes for people with a newly diagnosed, aggressive form of acute myeloid leukemia that has a TP53 mutation. The study aims to find a safe dose and see if the combination leads to more complete remissions. Participants will receive both drugs intravenously over several days in a hospital setting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bortezomib combined with CPX-351 (liposomal daunorubicin and cytarabine)
What this could lead to
If successful, this combination could offer a more effective treatment option for a hard-to-treat leukemia, potentially leading to higher remission rates and longer survival.
What could go wrong
This is an early-phase trial with a small number of participants, so the benefits are not yet proven. The combination may cause significant side effects, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 32 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Masonic Cancer Center

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

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