RecruitingPhase 1NCT06001788

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

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

Sponsor

Kura Oncology, Inc.

Enrollment

171 participants

Start Date

Feb 22, 2024

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests combinations of a new drug called ziftomenib with other treatments in patients with acute myeloid leukemia (AML) — a fast-growing blood cancer — that has come back or stopped responding to prior therapy, and has specific gene mutations. **You may be eligible if...** - You have been diagnosed with relapsed or refractory AML (leukemia that has returned or isn't responding to treatment) - Your AML has a confirmed NPM1 mutation or a KMT2A gene rearrangement - Some groups also require a FLT3 mutation (your doctor can check for this) - Your overall health and organ function (liver, kidneys, heart) meet the required levels - You are willing to use contraception as required by the study **You may NOT be eligible if...** - You have a type of leukemia called acute promyelocytic leukemia or blast crisis of CML - You have active leukemia that has spread to your brain or spinal cord (CNS leukemia) - You have an active, uncontrolled infection - Your heart function is below the required threshold Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZiftomenib

Oral administration

DRUGFludarabine

Intravenous infusion

DRUGIdarubicin

Intravenous infusion

DRUGCytarabine

Intravenous Infusion

DRUGGilteritinib

Oral administration

BIOLOGICALGranulocyte colony-stimulating factor

Subcutaneous injection

Locations(45)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

UCLA Health - Bowyer Oncology Center

Los Angeles, California, United States

UC Irvine Health Chao Family Comprehensive Cancer Center

Orange, California, United States

University of California San Francisco

San Francisco, California, United States

Colorado Blood Cancer Institute

Denver, Colorado, United States

Smilow Cancer Hospital at Yale New Haven

New Haven, Connecticut, United States

Emory Healthcare - The Emory Clinic

Atlanta, Georgia, United States

Georgia Cancer Center at Augusta University

Augusta, Georgia, United States

Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Chicago, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

Simmons Cancer Institute

Springfield, Illinois, United States

University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States

The University of Kansas Cancer Center

Kansas City, Kansas, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Henry Ford Cancer Institute

Detroit, Michigan, United States

Washington University School of Medicine

St Louis, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Northwell Health, LLC PRIME

Lake Success, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Weill Cornell Medical College-NY Presbyterian Hospital

New York, New York, United States

Wilmot Cancer Institute, University of Rochester

Rochester, New York, United States

Stony Brook Cancer Center

Stony Brook, New York, United States

Atrium Health Levine Cancer Center

Charlotte, North Carolina, United States

UH Seidman Cancer Center

Cleveland, Ohio, United States

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Lehigh Valley Topper Cancer Institute

Allentown, Pennsylvania, United States

Prisma Health

Greenville, South Carolina, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Dallas, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

University of Vermont

Burlington, Vermont, United States

University of Virginia Comprehensive Cancer Center

Charlottesville, Virginia, United States

University of Washington

Seattle, Washington, United States

Froedtert & Medical College Clinics

Milwaukee, Wisconsin, United States

IRCCS Azienda Ospedaliero-Universitaria do Bologna - Policlinico di Sant'Orsola

Bologna, Italy

Ospedale Santa Maria delle Croci

Ravenna, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Universitario Central de Asturias

Oviedo, Spain

Hospital Universitario Virgen del Rocío

Seville, Spain

Hospital Universitari y Politecnic La Fe

Valencia, Spain

View Full Details on ClinicalTrials.gov

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NCT06001788

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