Combining new drugs with chemotherapy for relapsed or refractory acute myeloid leukemia
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
This study is testing if adding new drugs, palbociclib or tazemetostat, to standard chemotherapy can help people with relapsed or refractory acute myeloid leukemia feel better and fight their cancer more effectively.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Thomas Jefferson University Academic / other |
| Drugs / interventions | chemotherapy, radiation, methotrexate |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05627232 on ClinicalTrials.gov |
What this trial studies
This phase I trial evaluates the safety and effectiveness of palbociclib or tazemetostat in combination with CPX-351 for patients with relapsed or refractory acute myeloid leukemia (AML). The study aims to determine the maximum tolerated doses of these enzyme inhibitors alongside standard chemotherapy. Participants will receive either tazemetostat or palbociclib before the chemotherapy, with assessments including bone marrow biopsies and blood sample collections. The goal is to enhance cancer cell death through this combination treatment approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with relapsed or refractory acute myeloid leukemia who have undergone at least one prior line of therapy.
Not a fit: Patients with acute myeloid leukemia that is not relapsed or refractory, or those with significant comorbidities affecting treatment tolerance, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with difficult-to-treat acute myeloid leukemia.
How similar studies have performed: While this approach is novel in the context of AML, similar combinations of chemotherapy with targeted therapies have shown promise in other cancers.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Philadelphia, Pennsylvania
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Gina Keiffer, MD — Thomas Jefferson University
- Study coordinator: Gina Keiffer, MD
- Email: gina.keiffer@jefferson.edu
- Phone: 215-955-2929
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.