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New drug cocktail aims to beat back aggressive leukemia in older adults

NCT ID NCT05260528

Disease control Sponsor: Centre Hospitalier Universitaire de Nice Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests whether a newer chemotherapy drug called CPX-351 works better than standard chemo for adults aged 50 and older with a hard-to-treat form of acute myeloid leukemia (AML). About 248 people will be randomly assigned to receive either CPX-351 or standard chemo. The main goal is to see if CPX-351 leads to deeper remissions with less cancer left behind in the bone marrow.

What this could mean

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

Active substance
CPX-351 (a combination of two chemotherapy drugs, daunorubicin and cytarabine, in a liposomal formulation)
What this could lead to
If CPX-351 works better than standard chemo, it could become a new first-line treatment for older adults with harder-to-treat AML, improving remission rates and reducing relapse.
What could go wrong
This is a phase 2 trial, so results are still early. CPX-351 may not prove superior to standard chemo, and both treatments have serious side effects like infection and organ damage.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 248 people

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

Started

May 2023

Expected to finish

Feb 2030

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: 1. De novo AML 2. No MRC-defining cytogenetic lesion 3. No t(15;17), t(8;21), inv(16) or t(16;16) 4. No NPM1 gene mutation 5. No FLT3 mutated AML (FLT3 ITD or TKD) 6. Not previously treated except for short course hydroxyurea in patients presenting with high WBC count and/or tumor symptoms, 7. Age ≥ 50 years, 8. Performance status ≤ 2 (ECOG grading), 9. Patient must have adequate organ function as indicated detailed with laboratory values in the section IV of the protocol 10. Female patient of childbearing potential with a negative serum pregnancy test (β-hCG) within 72 hours prior to receiving the first dose of CPX-351 or 7+3. Female patient who is not actively breastfeeding at the time of study entry. 11. Female patient is either post-menopausal, free from menses for \> 2 years, surgically sterilized or willing to use 2 adequate barrier methods of contraception to prevent pregnancy, or agrees to not become pregnant throughout the study, starting with study screening 12. Male patient agrees to use an adequate method of contraception for the duration of the study. Men should be advised not to father a child while receiving CPX-351 or 7+3 and for 3 months after the last dose of study treatment . 13. Patient is available for periodic blood sampling, study related assessments, and appropriate clinical management at the treating institution for the duration of the study. 14. Patient has the ability to understand and willingness to sign an informed consent form indicating the investigational nature of the study. 15. Patient registered to the French Social Security. Exclusion Criteria: 1. Prior history of documented MDS, MPN or MDS/MPN, tAML 2. Prior history of radiation therapy or chemotherapy for a solid tumor or lymphoma (exceptions to be considered: local radiotherapy for prostate cancer) 3. Patient has active and uncontrolled infection. 4. Patient has uncontrolled intercurrent illness or circumstances that could limit compliance with the study, including but not limited to the following: symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, pancreatitis, or psychiatric or social conditions that may interfere with patient compliance. 5. Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of initial dosing with study drug. 6. Patient has known human immunodeficiency virus (HIV) infection or HIV-related malignancy. 7. Patient has clinically active hepatitis B or hepatitis C infection. 8. Patient has a known allergy or hypersensitivity to any component of CPX-351, idarubicin or cytarabine. 9. Patient with a "currently active" second malignancy, other than nonmelanoma skin cancer and carcinoma in situ of the cervix, should not be enrolled. Patients are not considered to have a "currently active" malignancy if they have completed therapy for a prior malignancy, are disease free from prior malignancies for \>1 year or are considered by their physician to be at less than 30% risk of relapse. 10. Patients with clinical evidence of CNS leukemia. 11. Cardiac ejection fraction \<50% or considered as abnormal by echocardiography or multi-gated acquisition (MUGA) scan. 12. Patient is pregnant or breastfeeding within the projected duration of the study.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia

As listed by the trial registrant

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

Acute myeloid leukemia

How to take part

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

  1. The places running it

    35 sites. 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

  • CH Avignon

    RECRUITING

    Avignon, France

  • CH de Roubaix

    RECRUITING

    Roubaix, France

  • CHR Metz-Thionville Site Mercy

    RECRUITING

    Metz, France

  • CHR Orléans

    RECRUITING

    Orléans, France

  • CHRU Jean Minjoz

    RECRUITING

    Besançon, France

  • CHU Amiens Picardie site Sud

    RECRUITING

    Amiens, France

  • CHU Estaing

    RECRUITING

    Clermont-Ferrand, France

  • CHU Henri Mondor

    RECRUITING

    Créteil, France

  • CHU d'Angers

    NOT_YET_RECRUITING

    Angers, France

  • CHU de Bordeaux

    RECRUITING

    Pessac, France

  • CHU de Limoges

    RECRUITING

    Limoges, France

  • CHU de Nantes

    NOT_YET_RECRUITING

    Nantes, France

  • CHU de Nice

    RECRUITING

    Nice, France

  • CHU de Saint Etienne

    RECRUITING

    Saint-Priest-en-Jarez, France

  • CHU de Toulouse

    RECRUITING

    Toulouse, France

  • Centre Antoine Lacassagne

    NOT_YET_RECRUITING

    Nice, France

  • Centre Henri Becquerel

    RECRUITING

    Rouen, France

  • Centre Hospitalier Sud Francilien (CHSF)

    RECRUITING

    Corbeil-Essonnes, France

  • Centre Hospitalier de Béziers

    RECRUITING

    Béziers, France

  • Centre Hospitalier de Versailles, Site André Mignot

    RECRUITING

    Le Chesnay, France

  • Groupe hospitalier de la région de Mulhouse et Sud-Alsace, Hôpital Emile Muller

    RECRUITING

    Mulhouse, France

  • Hopital Bretonneau

    RECRUITING

    Tours, France

  • Hopital Lyon Sud

    RECRUITING

    Pierre-Bénite, France

  • Hopital Necker

    RECRUITING

    Paris, France

  • Hoptial de la Conception APHM

    RECRUITING

    Marseille, France

  • Hôpital Avicenne APHP

    RECRUITING

    Bobigny, France

  • Hôpital Claude HURIEZ, CHU Lille

    RECRUITING

    Lille, France

  • Hôpital Saint-Antoine

    RECRUITING

    Paris, France

  • Hôpital Saint-Louis

    RECRUITING

    Paris, France

  • Hôpital d'Instruction des Armée (HIA)

    RECRUITING

    Clamart, France

  • Hôpital de la Pitié Salpêtrière

    RECRUITING

    Paris, France

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, France

  • Institut Paoli Calmettes

    RECRUITING

    Marseille, France

  • Institut d'hématologie de Basse Normandie (IHBN)

    RECRUITING

    Caen, France

  • Institut de cancérologie du Gard

    RECRUITING

    Nîmes, France

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