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Clinical Trials in the USA / NCT06001788
Recruiting Phase 1

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

NCT06001788 · tracked via the Priya Life Science USA tracker
Sponsor
Kura Oncology, Inc.
Phase
Phase 1
Started
2024-02-22
Last updated
2026-08-20

Condition(s) studied

AMLAML With Mutated NPM1Hematologic MalignancyKMT2ArNPM1 MutationMLL RearrangementLeukemiaAcute Myeloid LeukemiaLeukemia, MyeloidLeukemia, Myeloid, AcuteAcute LeukemiaNeoplasms by Histologic Type

Investigational drug(s) / intervention(s)

ZiftomenibFludarabineIdarubicinCytarabineGilteritinibGranulocyte colony-stimulating factor

Ziftomenib: Oral administration

Fludarabine: Intravenous infusion

Idarubicin: Intravenous infusion

Cytarabine: Intravenous Infusion

Gilteritinib: Oral administration

Granulocyte colony-stimulating factor: Subcutaneous injection

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (45)

FacilityCityRegionStatus
Banner MD Anderson Cancer Center Gilbert Arizona Recruiting
USC Norris Comprehensive Cancer Center Los Angeles California Recruiting
UCLA Health - Bowyer Oncology Center Los Angeles California Recruiting
UC Irvine Health Chao Family Comprehensive Cancer Center Orange California Recruiting
University of California San Francisco San Francisco California Recruiting
Colorado Blood Cancer Institute Denver Colorado Recruiting
Smilow Cancer Hospital at Yale New Haven New Haven Connecticut Recruiting
Emory Healthcare - The Emory Clinic Atlanta Georgia Recruiting
Georgia Cancer Center at Augusta University Augusta Georgia Recruiting
Robert H. Lurie Comprehensive Cancer Center of Northwestern University Chicago Illinois Recruiting
Loyola University Medical Center Maywood Illinois Recruiting
Simmons Cancer Institute Springfield Illinois Withdrawn
University of Iowa Hospitals & Clinics Iowa City Iowa Recruiting
The University of Kansas Cancer Center Kansas City Kansas Recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts Recruiting
Karmanos Cancer Institute Detroit Michigan Recruiting
Henry Ford Cancer Institute Detroit Michigan Recruiting
Washington University School of Medicine St Louis Missouri Recruiting
University of Nebraska Medical Center Omaha Nebraska Recruiting
John Theurer Cancer Center at Hackensack University Medical Center Hackensack New Jersey Recruiting
Roswell Park Comprehensive Cancer Center Buffalo New York Recruiting
Northwell Health, LLC PRIME Lake Success New York Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Weill Cornell Medical College-NY Presbyterian Hospital New York New York Recruiting
Wilmot Cancer Institute, University of Rochester Rochester New York Recruiting
Stony Brook Cancer Center Stony Brook New York Recruiting
Atrium Health Levine Cancer Center Charlotte North Carolina Recruiting
UH Seidman Cancer Center Cleveland Ohio Recruiting
OU Health Stephenson Cancer Center Oklahoma City Oklahoma Recruiting
Lehigh Valley Topper Cancer Institute Allentown Pennsylvania Withdrawn
Prisma Health Greenville South Carolina Recruiting
Vanderbilt University Medical Center Nashville Tennessee Recruiting
Texas Oncology - Baylor Charles A. Sammons Cancer Center Dallas Texas Recruiting
MD Anderson Cancer Center Houston Texas Recruiting
University of Vermont Burlington Vermont Recruiting
University of Virginia Comprehensive Cancer Center Charlottesville Virginia Recruiting
University of Washington Seattle Washington Recruiting
Froedtert & Medical College Clinics Milwaukee Wisconsin Recruiting
IRCCS Azienda Ospedaliero-Universitaria do Bologna - Policlinico di Sant'Orsola Bologna Italy Recruiting
Ospedale Santa Maria delle Croci Ravenna Italy Recruiting

+ 5 more sites — see the full list on the official registry below.

More Kura Oncology, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06001788 on ClinicalTrials.gov ↗ ← All trials in the USA