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RECRUITING
NCT05627232
PHASE1

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

Sponsor: Thomas Jefferson University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2023-08-28

Completion Date

2029-01

Last Updated

2026-03-12

Healthy Volunteers

No

Interventions

DRUG

Tazemetostat

Given PO

DRUG

Liposome-encapsulated Daunorubicin-Cytarabine

Given IV

PROCEDURE

Bone Marrow Aspiration and Biopsy

Undergo bone marrow aspiration and biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

Palbociclib

Given PO

Locations (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States