Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Launched by KURA ONCOLOGY, INC. · Aug 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ziftomenib, which is being tested in combination with standard therapies for patients with relapsed or refractory acute myeloid leukemia (AML). The goal is to find out how safe this combination is and how well it works in helping to manage the disease. The trial is open to adults, particularly those who have specific genetic changes associated with their leukemia, including an NPM1 mutation or KMT2A rearrangement.

To participate, patients need to have a diagnosis of relapsed or refractory AML and meet certain health criteria, such as having good liver and kidney function. They should also be able to understand the study details and provide consent. Participants will receive the ziftomenib treatment alongside other medications, and they will be closely monitored for their safety and response to the therapy. It’s important to note that some individuals, such as those with certain other types of leukemia or active infections, may not be eligible to join the trial. This study aims to offer new hope for patients who have not responded well to previous treatments.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Has been diagnosed with relapsed/refractory AML.
• • Has a documented NPM1 mutation or KMT2A rearrangement.
• • Has a documented FLT3 mutation (cohort A-3 only).
• • Has an Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2.
• • Has adequate hepatic and renal function as defined per protocol.
• • Has an ejection fraction above a protocol defined limit.
• • Participant, or legally authorized representative, must be able to understand and provide written informed consent prior to the first screening procedure.
• • Has agreed to use contraception as defined per protocol.
• Key Exclusion Criteria:
• • Has a diagnosis of acute promyelocytic leukemia or blast chronic myeloid leukemia.
• • Has clinically active central nervous system leukemia.
• • Has an active and uncontrolled infection.
• • Has a mean corrected QT interval (QTcF) \> 480ms.
• • Has uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease.
• • Has received radiation, chemotherapy, immunotherapy, or any other anticancer therapy including investigational therapy \<14 days or within 5 drug half-lives prior to the first dose of study intervention.
• • Has had major surgery within 4 weeks prior to the first dose of study intervention.
• • Has received a hematopoietic stem cell transplant (HSCT) and has not previously had adequate recovery per protocol defined criteria.
• • Has active graft-versus-host disease (GvHD) and or on immunosuppressive drugs for the treatment of GvHD.
• • Participant is pregnant or lactating.