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RecruitingPhase 1

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

A Two-Part Phase 1b Study Evaluating the Combination of Tazemetostat and CPX-351 (Part 1) and Palbociclib Pre-Treatment Followed by CPX-351 (Part 2) for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for adults with acute myeloid leukemia (AML), a blood cancer, that came back or did not respond to treatment. It tests tazemetostat with CPX-351 in one part and palbociclib before CPX-351 in the other. Researchers will check safety, find doses for further study, and look for early signs that the treatments work.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older with confirmed AML, other than the M3 type, that came back or did not respond to at least one treatment.
  • Sign a consent form and be willing to follow study steps and stay in the study.
  • Have a bone marrow test to confirm AML, unless enough immature leukemia cells are found in the blood.
  • Be able to care for yourself and be up and about at least half of waking hours. Be expected to live at least 4 weeks.
  • Be able to take medicine by mouth.
  • Have only mild or no lasting side effects from past treatment, except hair loss. Any experimental drug must have been stopped at least 2 weeks before joining.
  • Meet kidney and liver blood test limits: creatinine clearance of at least 45 and bilirubin below twice the upper normal limit.
  • Have a negative pregnancy test if you can become pregnant.

Who can't join

  • Have acute promyelocytic leukemia, a type of AML, or active leukemia in the brain or spinal cord.
  • Be receiving chemotherapy other than hydroxyurea or methotrexate or cytarabine given into spinal fluid. Drugs that help blood cells grow are not allowed, except erythropoietin.
  • Joining would bring your total daunorubicin dose above 550 mg/m², or above 450 mg/m² if you had radiation to the middle of your chest.
  • Have another active cancer, except nonmelanoma skin cancer, cancer limited to the surface of the cervix, or removed prostate cancer with a Gleason score of 6 or less.
  • Have unstable heart disease or an uncontrolled irregular heartbeat.
  • Have another serious illness that makes intensive treatment unsafe, or any condition that raises risk or prevents finishing study steps.
  • Be pregnant or breastfeeding.
  • Have a known allergy to any ingredient in the study drugs.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 biopsy is not necessary to meet this criterion * 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 * Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less * Life expectancy of at least 4 weeks * Must be able to consume oral medication * Subjects must have recovered from the toxic effect of any prior therapy to =\< grade 1 (except alopecia) * Creatine clearance (CrCL) \>= 45 * Total bilirubin \< 2 x upper limit of normal (ULN) * Female subjects of childbearing age must have a negative pregnancy test Exclusion Criteria: * 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/m\^2 or greater than 450 mg/m\^2 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 * Subjects must not be receiving growth factors (except erythropoietin) * Subjects with currently active second malignancy with the exception of nonmelanoma skin cancer, carcinoma in situ of the cervix, resected prostate cancer with Gleason score =\< 6 * Subjects with unstable cardiac disease or uncontrolled arrhythmia * Subjects with other severe concurrent disease which, in the judgement of the investigator, would make the patient inappropriate to receive high-intensity therapy * Subjects who are pregnant or breastfeeding * Subjects with known allergic reactions to components of the study product(s) * Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study

Study sites (1)

PA