RecruitingPhase 1NCT05627232

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

A Two-Part Phase 1b Study Evaluating the Combination of Tazemetostat and CPX-351 (Part 1) and Palbociclib Pre-Treatment Followed by CPX-351 (Part 2) for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

Sponsor

Thomas Jefferson University

Enrollment

24 participants

Start Date

Aug 28, 2023

Study Type

INTERVENTIONAL

Conditions

Recurrent Acute Myeloid Leukemia Refractory Acute Myeloid Leukemia

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a three-drug combination — tazemetostat, palbociclib, and CPX-351 — for people with acute myeloid leukemia (AML, a fast-growing blood cancer) that has come back or stopped responding to at least one prior treatment. Each drug targets different pathways that leukemia cells rely on to survive and grow. **You may be eligible if...** - You are 18 or older with confirmed AML that has relapsed or is refractory to prior therapy - You are generally active (ECOG performance status 2 or less) - You have adequate kidney and liver function - You are able to take medication by mouth **You may NOT be eligible if...** - You have acute promyelocytic leukemia (a specific subtype, APL) - Your AML has spread to the brain or spinal cord - You are currently receiving chemotherapy (with some exceptions like hydroxyurea) - You have another active cancer (minor exceptions apply) - You have serious, unstable heart disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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