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Tazemetostat and Palbociclib with CPX-351 for Relapsed/Refractory AML

This study is testing new combinations of medicines for people with acute myeloid leukemia (AML) that has come back (relapsed) or hasn't responded to previous treatments (refractory). Researchers are looking at the safety and how well tazemetostat and palbociclib work when given with CPX-351 (Liposome-encapsulated Daunorubicin-Cytarabine). The study aims to find the best dose of these combinations. You would be eligible if you are at least 18 years old and have AML that has relapsed or is refractory after at least one prior treatment. The main goal is to see how many serious side effects occur within one year. The study plans to enroll 24 participants, but its current status is unclear.

Study design
This is a two-part, single-institution, dose-escalation study (Phase 1b) that will enroll 24 participants. It uses a traditional 3+3 design to find the recommended dose of the drug combinations.
What's involved
You would undergo bone marrow aspiration and biopsy, and blood sample collection. The duration of your participation is not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures side effects for up to one year after treatment.

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

NCT05627232

Tazemetostat and Palbociclib With CPX-351for R/R AML

Recruiting
PHASE1Ages 18+InterventionalTreatment
Thomas Jefferson University
~24 participants
Updated 2026-03-12 on ClinicalTrials.gov
What's tested:TazemetostatLiposome-encapsulated Daunorubicin-CytarabineBone Marrow Aspiration and BiopsyBiospecimen CollectionPalbociclib

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of grade >= 3 non-hematologic dose limiting toxicities
Measured over Up to 1 year

Conditions

Recurrent Acute Myeloid Leukemia
Refractory Acute Myeloid Leukemia

Explore related trials

Acute Myeloid Leukemia

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Gina Keiffer, MD · PRINCIPAL_INVESTIGATOR · Thomas Jefferson University

Who to contact

Gina Keiffer, MD
[email protected]
215-955-2929
Email the study team

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Eligibility criteria

Inclusion

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:
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

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

What this trial measures

  • Incidence of grade >= 3 non-hematologic dose limiting toxicitiesUp to 1 year

    The primary outcome measure will be grade \>= 3 non-hematologic dose limiting toxicities. Adverse events will be coded by organ system and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5.0. the calculation of adverse events incidences will be passed on number of patients per adverse event category. Standard proportions will be used to report rates of safety endpoints. Summary tables will be presented by dose level, seriousness, severity and relatedness.