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Tazemetostat and Palbociclib With CPX-351for R/R AML
Sponsor: Thomas Jefferson University
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
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
Locations (1)
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States