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New treatment option for Recurrent Acute Myeloid Leukemia
Official title Tazemetostat and Palbociclib With CPX-351for R/R AML
ClinicalTrials.gov ID: NCT05627232
What this study is testing
What is Tazemetostat?
Tazemetostat is an investigational medicine, being studied as a potential treatment for recurrent acute myeloid leukemia.
Also referred to as 1403254-99-8, E7438.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- people with acute promyelocytic leukemia
- people receiving any active chemotherapy agents (except hydroxyurea). Intrathecal methotrexate and cytarabine are permissible
- people 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...
- people with evidence of active central nervous system (CNS) leukemia involvement. Lumbar puncture is not required for enrollment in the absence of...
- people must not be receiving growth factors (except erythropoietin)
- people with currently active second malignancy with the exception of nonmelanoma skin cancer, carcinoma in situ of the cervix, resected prostate...
See the full 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 biopsy within 28 days of screening is acceptable. If no prior bone...
- 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...
- 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
- people 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 people of childbearing age must have a negative pregnancy test
- people with acute promyelocytic leukemia
- people receiving any active chemotherapy agents (except hydroxyurea). Intrathecal methotrexate and cytarabine are permissible
- people 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
- people with evidence of active central nervous system (CNS) leukemia involvement. Lumbar puncture is not required for enrollment in the absence of neurologic symptoms
- people must not be receiving growth factors (except erythropoietin)
- people 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
- people with unstable cardiac disease or uncontrolled arrhythmia
- people with other severe concurrent disease which, in the judgement of the investigator, would make the patient inappropriate to receive high-intensity therapy
- people who are pregnant or breastfeeding
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.