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Experimental combo aims to outsmart tough leukemia

NCT ID NCT05627232

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-phase trial tests two different drug combinations for people whose acute myeloid leukemia (AML) has returned or not responded to prior treatment. In Part 1, participants receive tazemetostat plus a standard chemotherapy called CPX-351. In Part 2, they get palbociclib before CPX-351. The study enrolls 24 adults and focuses on finding safe doses and watching for side effects.

What this could mean

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

Active substance
tazemetostat and CPX-351 (liposomal daunorubicin-cytarabine) in Part 1; palbociclib followed by CPX-351 in Part 2
What this could lead to
If successful, this could point toward a new combination treatment for acute myeloid leukemia that has come back or not responded to standard therapy.
What could go wrong
This is a very early (Phase 1) trial with only 24 participants, so the main goal is safety, not proof of effectiveness. The combinations may cause serious side effects or fail to improve outcomes.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 24 people

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

Started

Aug 2023

Expected to finish

Jan 2029

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: * Provide signed and dated informed consent form * Willing to comply with all study procedures and be available for the duration of the study * Male or female \>= 18 years of age * Histologically confirmed acute myeloid leukemia (non-M3) relapsed from or refractory to at least 1 prior line of therapy. Bone marrow aspirate and biopsy within 28 days of screening is acceptable. If no prior bone marrow biopsy is available, bone marrow biopsy must be performed during screening unless: \* If the subject has \>= 20% myeloblasts present in the peripheral blood, a bone marrow biopsy is not necessary to meet this criterion * Treatment with a prior investigational agent is acceptable so long as it has not been administered within 2 weeks of enrollment and any prior adverse effects have resolved to grade 1 or less with the exception of alopecia * Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less * Life expectancy of at least 4 weeks * Must be able to consume oral medication * Subjects must have recovered from the toxic effect of any prior therapy to =\< grade 1 (except alopecia) * Creatine clearance (CrCL) \>= 45 * Total bilirubin \< 2 x upper limit of normal (ULN) * Female subjects of childbearing age must have a negative pregnancy test Exclusion Criteria: * Subjects with acute promyelocytic leukemia * Subjects receiving any active chemotherapy agents (except hydroxyurea). Intrathecal methotrexate and cytarabine are permissible * Subjects whose participation would result in a total cumulative dose of daunorubicin greater than 550 mg/m\^2 or greater than 450 mg/m\^2 if they previously received mediastinal radiation * Subjects with evidence of active central nervous system (CNS) leukemia involvement. Lumbar puncture is not required for enrollment in the absence of neurologic symptoms * Subjects must not be receiving growth factors (except erythropoietin) * Subjects with currently active second malignancy with the exception of nonmelanoma skin cancer, carcinoma in situ of the cervix, resected prostate cancer with Gleason score =\< 6 * Subjects with unstable cardiac disease or uncontrolled arrhythmia * Subjects with other severe concurrent disease which, in the judgement of the investigator, would make the patient inappropriate to receive high-intensity therapy * Subjects who are pregnant or breastfeeding * Subjects with known allergic reactions to components of the study product(s) * Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study

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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

  • Thomas Jefferson University Hospital

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

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