Tazemetostat and Palbociclib With CPX-351for R/R AML
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorThomas Jefferson University
About this trial
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.
Eligibility criteria
Qualifiers
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
Treatment with a prior investigational agent is acceptable so long as it has not been administered within 2 weeks of enrollment and any prior adverse effects have resolved to grade 1 or less with the exception of alopecia
Disqualifiers
Subjects with acute promyelocytic leukemia
Subjects receiving any active chemotherapy agents (except hydroxyurea). Intrathecal methotrexate and cytarabine are permissible
Subjects whose participation would result in a total cumulative dose of daunorubicin greater than 550 mg/m² or greater than 450 mg/m² if they previously received mediastinal radiation
Subjects with evidence of active central nervous system (CNS) leukemia involvement. Lumbar puncture is not required for enrollment in the absence of neurologic symptoms
Trial design
Treatments tested in this trial
- Tazemetostat
- Liposome-encapsulated Daunorubicin-Cytarabine
- Bone Marrow Aspiration and Biopsy
- Biospecimen Collection
- Palbociclib
Treatment groups
24 Participants
are divided into 2 treatment groupsSponsors and collaborators
Thomas Jefferson University
Lead sponsor
Pennsylvania Department of Health
Collaborator
Source ClinicalTrials.gov