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

RecruitingPhase 1

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

Who can join

Ages 18 and older · All sexes

Full 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 (cA-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.

About the study

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.

What is being tested

Sponsor: Kura Oncology, Inc. · Participants: 171 · Started: Feb 22, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06001788

Locations in the U.S.

ArizonaBanner MD Anderson Cancer Center, Gilbert
CaliforniaUCLA Health - Bowyer Oncology Center, Los Angeles
USC Norris Comprehensive Cancer Center, Los Angeles
UC Irvine Health Chao Family Comprehensive Cancer Center, Orange
University of California San Francisco, San Francisco
ColoradoColorado Blood Cancer Institute, Denver
ConnecticutSmilow Cancer Hospital at Yale New Haven, New Haven
GeorgiaEmory Healthcare - The Emory Clinic, Atlanta
Georgia Cancer Center at Augusta University, Augusta
IllinoisRobert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago
Loyola University Medical Center, Maywood
IowaUniversity of Iowa Hospitals & Clinics, Iowa City
KansasThe University of Kansas Cancer Center, Kansas City
MassachusettsBeth Israel Deaconess Medical Center, Boston
MichiganHenry Ford Cancer Institute, Detroit
Karmanos Cancer Institute, Detroit
MissouriWashington University School of Medicine, St Louis
NebraskaUniversity of Nebraska Medical Center, Omaha
New JerseyJohn Theurer Cancer Center at Hackensack University Medical Center, Hackensack
New YorkRoswell Park Comprehensive Cancer Center, Buffalo
Northwell Health, LLC PRIME, Lake Success
Memorial Sloan Kettering Cancer Center, New York
Weill Cornell Medical College-NY Presbyterian Hospital, New York
Wilmot Cancer Institute, University of Rochester, Rochester
Stony Brook Cancer Center, Stony Brook
North CarolinaAtrium Health Levine Cancer Center, Charlotte
OhioUH Seidman Cancer Center, Cleveland
OklahomaOU Health Stephenson Cancer Center, Oklahoma City
South CarolinaPrisma Health, Greenville
TennesseeVanderbilt University Medical Center, Nashville
TexasTexas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas
MD Anderson Cancer Center, Houston
VermontUniversity of Vermont, Burlington
VirginiaUniversity of Virginia Comprehensive Cancer Center, Charlottesville
WashingtonUniversity of Washington, Seattle
WisconsinFroedtert & Medical College Clinics, Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.