Thomas Jefferson University
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.
PRIMARY OBJECTIVE: Part 1: To determine the RDFE of tazemetostat in combination with CPX-351 in patients with R/R-AML. Part 2: To determine the RDFE of palbociclib pre-treatment prior to CPX-351 in patients with R/R-AML. SECONDARY OBJECTIVE: I. To evaluate the preliminary efficacy of tazemetostat in combination with CPX-351 (Part 1) and of palbociclib pre-treatment followed by CPX-351 (Part 2). EXPLORATORY OBJECTIVES: 1. To determine whether treatment with the EZH2 inhibitor tazemetostat de-condenses the H3K27me3-marked chromatin of AML blasts. 2. To determine whether cell cycle re-entry…
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 bi…
Given PO
Given IV
Undergo bone marrow aspiration and biopsy
Undergo blood sample collection
Given PO
Arctuva estimate
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