OncoMatch/Clinical Trials/NCT05627232
Tazemetostat and Palbociclib With CPX-351for R/R AML
Is NCT05627232 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Tazemetostat and Liposome-encapsulated Daunorubicin-Cytarabine for recurrent acute myeloid leukemia.
Treatment: Tazemetostat · Liposome-encapsulated Daunorubicin-Cytarabine · Palbociclib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received:
relapsed from or refractory to at least 1 prior line of therapy
Cannot have received: active chemotherapy (hydroxyurea)
Exception: hydroxyurea allowed; intrathecal methotrexate and cytarabine are permissible
Subjects receiving any active chemotherapy agents (except hydroxyurea). Intrathecal methotrexate and cytarabine are permissible
Cannot have received: growth factors (erythropoietin)
Exception: erythropoietin allowed
Subjects must not be receiving growth factors (except erythropoietin)
Lab requirements
Kidney function
creatine clearance (crcl) >= 45
Liver function
total bilirubin < 2 x upper limit of normal (uln)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Thomas Jefferson University Hospital · Philadelphia, Pennsylvania
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