SUSPENDED

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

Conditions

Recurrent Acute Myeloid Leukemia Refractory Acute Myeloid Leukemia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 following pre-treatment with palbociclib 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 Part 2 dose of tazemetostat in combination with standard-dose CPX-351. Once the recommended Part 2 dose is established, the study will proceed to Part 2 where pre-treatment with palbociclib will be administered prior to the tazemetostat/CPX-351 dose combination. The objective of Part 2 is to establish the optimal dose of palbociclib.).

Official Title

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

Quick Facts

Study Start:2023-08-28

Study Completion:2026-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:SUSPENDED

Study ID

NCT05627232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: * 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	* 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

Inclusion Criteria

Exclusion 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:
* 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

* 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

Contacts and Locations

Principal Investigator

Gina Keiffer, MD

PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Study Locations (Sites)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107

United States

Collaborators and Investigators

Sponsor: Thomas Jefferson University

Gina Keiffer, MD, PRINCIPAL_INVESTIGATOR, Thomas Jefferson University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-28

Study Completion Date2026-01

Study Record Updates

Study Start Date2023-08-28

Study Completion Date2026-01

Terms related to this study

Additional Relevant MeSH Terms

Recurrent Acute Myeloid Leukemia
Refractory Acute Myeloid Leukemia