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PhI Ziftomenib Comb Tx of KMT2A-rearranged or NPM1-mutant Relapsed/Refractory Acute Myeloid Leukemia

Kiran Naqvi


A Study On:

  • Myeloid and Monocytic Leukemia

Status:

  • Open

Eligibility

adult, older adult

Official Title

Phase I Study to Determine the Safety and Tolerability of Ziftomenib Combinations for the Treatment of KMT2A-Rearranged or NPM1-Mutant Relapsed/Refractory Acute Myeloid Leukemia

Details

The safety, tolerability, and antileukemic response of ziftomenib in combination with standard of care treatments for patients with relapsed/refractory acute myeloid leukemia will be examined with the following agents: FLAG-IDA, low-dose cytarabine, and gilteritinib.


Eligibility

You can join if...

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.

Get in touch with our study team