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

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-tr

Trial Details

NCT ID
NCT05627232
Phase
PHASE1
Sponsor
Thomas Jefferson University
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Tazemetostat
  • Liposome-encapsulated Daunorubicin-Cytarabine
  • Bone Marrow Aspiration and Biopsy
  • Biospecimen Collection
  • Palbociclib
Locations (sample)
  • Philadelphia, Pennsylvania, United States|39.95238,-75.16362

Key Eligibility 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 …

For full eligibility, visit ClinicalTrials.gov.

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