70 Participants Needed

Ziftomenib for Acute Myeloid Leukemia

OS
Overseen ByOhio State University Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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

UM

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

Signed informed consent must be obtained prior to participation in the study
Peripheral white blood cell (WBC) counts must be ≤ 10,000/uL
I cannot or do not want to receive standard initial treatment due to my age or health issues.
See 2 more

Exclusion Criteria

Detectable viral load for HIV, hepatitis C, or hepatitis B surface antigen indicative of active infection
I have conditions that increase my risk for serious infections.
Mean QTcF interval > 480 ms on ECG
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 visit (in-person)

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.

24 cycles (28 days each)
Monthly visits for each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-up every 6 months for up to 24 months.

24 months
Biannual visits

Treatment Details

Interventions

  • Ziftomenib
Trial Overview The trial is testing ziftomenib, a drug designed to block the menin pathway which may be involved in AML growth due to NPM1 or KMT2A gene changes. The study includes collecting biospecimens, bone marrow procedures, heart tests, and administering additional drugs like cytarabine.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment (ziftomenib)Experimental Treatment10 Interventions
Patients receive ziftomenib PO QD 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. Patients may also undergo cytoreduction therapy with hydroxyurea up to end of cycle 1, cytarabine within 7 days of starting treatment, or leukapheresis within 7 days of treatment to reduce white blood cell count to =\< 10,000/uL. Additionally, patients undergo ECHO or MUGA at screening and bone marrow biopsy and/or aspiration and blood sample collection throughout the study.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Uma Borate

Lead Sponsor

Trials
7
Recruited
310+

Kura Oncology

Collaborator

Trials
2
Recruited
110+
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