OncoMatch/Clinical Trials/NCT05627232
Tazemetostat and Palbociclib With CPX-351for R/R AML
Is NCT05627232 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Targeted therapy
Other
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05627232 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior active chemotherapy, growth factors disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages