Ziftomenib for Acute Myeloid Leukemia
Trial Summary
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop all current medications, but you cannot take drugs that strongly affect a liver enzyme called CYP3A4, except for certain antibiotics, antifungals, and antivirals. You can continue using hydroxyurea or cytarabine to control white blood cell counts.
What is the purpose of this trial?
This phase II trial tests how well ziftomenib works in treating patients with NPM1 mutated or KMT2A rearranged acute myeloid leukemia (AML) and are not eligible to receive standard therapy. AML is often due to genetic changes in the cancer cells, including mutations in the NPM1 gene and rearrangements involving the KMT2A gene. These mutations result in activation of the menin pathway. Menin is a type of protein in the body that helps to regulate some of the naturally occurring processes in the body, but can also be involved in some types of cancers. Ziftomenib blocks this menin pathway and may prevent the cancer cells from continuing to grow. Giving ziftomenib may kill more cancer cells in patients with NPM1 mutated or KMT2A rearranged AML that are not eligible to receive standard therapy.
Research Team
Uma M Borate, MBBS, MD, MSc
Principal Investigator
Ohio State University Comprehensive Cancer Center
Eligibility Criteria
This trial is for patients with acute myeloid leukemia (AML) who have specific genetic changes (NPM1 mutations or KMT2A rearrangements) and cannot receive standard therapy. It's important that participants haven't had certain treatments before, are not pregnant, and do not have other serious medical conditions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ziftomenib orally once daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-up every 6 months for up to 24 months.
Treatment Details
Interventions
- Ziftomenib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Uma Borate
Lead Sponsor
Kura Oncology
Collaborator