Recruiting
Phase 1

Palbociclib & Tazemetostat

Sponsor:

Thomas Jefferson University

Code:

NCT05627232

Conditions

Recurrent Acute Myeloid Leukemia

Refractory Acute Myeloid Leukemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tazemetostat

Liposome-encapsulated Daunorubicin-Cytarabine

Bone Marrow Aspiration and Biopsy

Biospecimen Collection

Palbociclib

Study Details

Brief summary:

This is a two-part phase Ib dose escalation study to evaluate the safety and preliminary efficacy of the combination of tazemetostat and CPX-351 (Part 1) and of pre-treatment with palbociclib followed by CPX-351 (Part 2) for patients with relapsed or refractory (R/R) acute myeloid leukemia (AML). Part 1 of the study will seek to establish the safety, tolerability, biological activity and recommended dose for further evaluation (RDFE) of tazemetostat in combination with standard-dose CPX-351. Part 2 of the study will seek to establish the safety, tolerability, biological activity RDFE of pre-treatment palbociclib prior CPX-351.

Conditions

Recurrent Acute Myeloid Leukemia

Refractory Acute Myeloid Leukemia

Study ID

NCT05627232

Start date

Aug 28, 2023

Status verified date

Mar, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part I (tazemetostat, CPX-351)

Patients receive tazemetostat PO BID on days -1 to 6, and CPX-351 IV over 90 minutes on days 1, 3, and 5. Patients also undergo bone marrow aspiration and biopsy and blood sample collection during screening and on study.

experimental: Part II: (Palbociclib Pre-Treatment Followed by CPX-351)

Patients receive palbociclib PO QD on days -3 to -1 and CPX-351 IV over 90 minutes on days 1, 3, and 5. Patients also undergo bone marrow aspiration and biopsy and blood sample collection during screening and on study.

Interventions

Tazemetostat

Given PO

Liposome-encapsulated Daunorubicin-Cytarabine

Given IV

Bone Marrow Aspiration and Biopsy

Undergo bone marrow aspiration and biopsy

Biospecimen Collection

Undergo blood sample collection

Palbociclib

Given PO

Primary outcome measure

  • Incidence of grade >= 3 non-hematologic dose limiting toxicities [ Time Frame: Up to 1 year ]

Central Contacts and Locations

Central contacts

Gina Keiffer, MD

215-955-2929gina.keiffer@jefferson.edu

Locations

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Gina Keiffer, MD

215-955-2929gina.keiffer@jefferson.edu

More Information

Sponsor

Thomas Jefferson University

Last update posted

Mar 12, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2026-03-12.