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

Description

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.

Conditions

AML, AML With Mutated NPM1, Hematologic Malignancy, KMT2Ar, NPM1 Mutation, MLL Rearrangement, Leukemia, Acute Myeloid Leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute, Acute Leukemia, Neoplasms by Histologic Type

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Study Overview

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Study Details

Study overview

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.

Phase 1 Study to Determine the Safety and Tolerability of Ziftomenib Combinations for the Treatment of KMT2A-rearranged or NPM1-mutant Relapsed/Refractory Acute Myeloid Leukemia

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

Condition
AML
Intervention / Treatment

-

Contacts and Locations

Gilbert

Banner MD Anderson Cancer Center, Gilbert, Arizona, United States, 85234

Los Angeles

UCLA Health - Bowyer Oncology Center, Los Angeles, California, United States, 90095

Orange

UCI Health Chao Family Comprehensive Cancer Center, Orange, California, United States, 92868

New Haven

Smilow Cancer Hospital at Yale New Haven, New Haven, Connecticut, United States, 06511

Kansas City

The University of Kansas, Kansas City, Kansas, United States, 66160

Detroit

Karmanos Cancer Institute, Detroit, Michigan, United States, 48201

Detroit

Henry Ford Cancer Institute, Detroit, Michigan, United States, 48202

Omaha

University of Nebraska Medical Center, Omaha, Nebraska, United States, 68198

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10021

Stony Brook

Stony Brook Cancer Center, Stony Brook, New York, United States, 11794

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Kura Oncology, Inc.,

Clinical Development, STUDY_DIRECTOR, Kura Oncology

Study Record Dates

2027-08