Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05627232

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

Led by Thomas Jefferson University · Updated on 2026-03-12

24

Participants Needed

1

Research Sites

279 weeks

Total Duration

On this page

Sponsors

T

Thomas Jefferson University

Lead Sponsor

P

Pennsylvania Department of Health

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 or older
  • 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 or >20% myeloblasts in peripheral blood
  • Treatment with prior investigational agent allowed if not given within 2 weeks of enrollment and side effects resolved to grade 1 or less except alopecia
  • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
  • Life expectancy of at least 4 weeks
  • Able to consume oral medication
  • Recovery from toxic effects of any prior therapy to grade 1 or less except alopecia
  • Creatinine clearance of 45 or higher
  • Total bilirubin less than 2 times the upper limit of normal
  • Female subjects of childbearing age must have a negative pregnancy test
Not Eligible

You will not qualify if you...

  • Acute promyelocytic leukemia
  • Receiving any active chemotherapy agents except hydroxyurea or intrathecal methotrexate and cytarabine
  • Prior cumulative daunorubicin dose over 550 mg/m2 or over 450 mg/m2 with prior mediastinal radiation
  • Active central nervous system leukemia involvement
  • Receiving growth factors except erythropoietin
  • Active second malignancy except nonmelanoma skin cancer, carcinoma in situ of cervix, or resected prostate cancer with Gleason score 6 or less
  • Unstable cardiac disease or uncontrolled arrhythmia
  • Other severe concurrent disease making high-intensity therapy inappropriate
  • Pregnant or breastfeeding
  • Known allergic reaction to study product components
  • Any condition increasing risk or preventing full compliance with study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

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Research Team

G

Gina Keiffer, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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