Back to Trials
NCT06001788PHASE1Recruiting

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

Kura Oncology, Inc.

Start Date

2/22/2024

Completion Date

8/1/2027

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 Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Ziftomenib

DRUG

Fludarabine

DRUG

Idarubicin

DRUG

Cytarabine

DRUG

Gilteritinib

BIOLOGICAL

Granulocyte colony-stimulating factor

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

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

Locations

Banner MD Anderson Cancer Center

Gilbert, Arizona 85234

United States

USC Norris Comprehensive Cancer Center

Los Angeles, California 90089

United States

UCLA Health - Bowyer Oncology Center

Los Angeles, California 90095

United States

UC Irvine Health Chao Family Comprehensive Cancer Center

Orange, California 92868

United States

University of California San Francisco

San Francisco, California 94115

United States

Colorado Blood Cancer Institute

Denver, Colorado 80218

United States

Smilow Cancer Hospital at Yale New Haven

New Haven, Connecticut 06511

United States

Emory Healthcare - The Emory Clinic

Atlanta, Georgia 30322

United States

Georgia Cancer Center at Augusta University

Augusta, Georgia 30912

United States

Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Chicago, Illinois 60611

United States

Loyola University Medical Center

Maywood, Illinois 60153

United States

Simmons Cancer Institute

Springfield, Illinois 62702

United States

University of Iowa Hospitals & Clinics

Iowa City, Iowa 52242

United States

The University of Kansas Cancer Center

Kansas City, Kansas 66160

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

Karmanos Cancer Institute

Detroit, Michigan 48201

United States

Henry Ford Cancer Institute

Detroit, Michigan 48202

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

University of Nebraska Medical Center

Omaha, Nebraska 68198

United States

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey 07601

United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York 14263

United States

Northwell Health, LLC PRIME

Lake Success, New York 11042

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10021

United States

Weill Cornell Medical College-NY Presbyterian Hospital

New York, New York 10065

United States

Wilmot Cancer Institute, University of Rochester

Rochester, New York 14642

United States

Stony Brook Cancer Center

Stony Brook, New York 11794

United States

Atrium Health Levine Cancer Center

Charlotte, North Carolina 60201

United States

UH Seidman Cancer Center

Cleveland, Ohio 44106

United States

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma 73104

United States

Lehigh Valley Topper Cancer Institute

Allentown, Pennsylvania 18103

United States

Prisma Health

Greenville, South Carolina 29615

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Dallas, Texas 75246

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States

University of Vermont

Burlington, Vermont 05401

United States

University of Virginia Comprehensive Cancer Center

Charlottesville, Virginia 22903

United States

University of Washington

Seattle, Washington 98109

United States

Froedtert & Medical College Clinics

Milwaukee, Wisconsin 53226

United States

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

Bologna, 40138

Italy

Ospedale Santa Maria delle Croci

Ravenna, 48121

Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168

Italy

Hospital Universitari Vall d'Hebron

Barcelona, 08035

Spain

Hospital Universitario Central de Asturias

Oviedo, 33011

Spain

Hospital Universitario Virgen del Rocío

Seville, 41013

Spain

Hospital Universitari y Politecnic La Fe

Valencia, 46026

Spain