Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
completion around

Description

Summary

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.

Official Title

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

Keywords

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, Myeloid Leukemia, Hematologic Neoplasms, Cytarabine, Fludarabine, Idarubicin, Lenograstim, Gilteritinib, Ziftomenib, Granulocyte colony-stimulating factor

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • UCI Health Chao Family Comprehensive Cancer Center accepting new patients
    Orange California 92868 United States
  • OU Health Stephenson Cancer Center accepting new patients
    Oklahoma City Oklahoma 73104 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Kura Oncology, Inc.
ID
NCT06001788
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 171 study participants
Last Updated