RecruitingPhase 1NCT05735184

A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AML

Phase 1 Study of Venetoclax/Azacitidine or Venetoclax in Combination With Ziftomenib or Standard Induction Cytarabine/Daunorubicin (7+3) Chemotherapy in Combination With Ziftomenib for the Treatment of Patients With Acute Myeloid Leukemia

Sponsor

Kura Oncology, Inc.

Enrollment

420 participants

Start Date

Jul 18, 2023

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia Myeloid Sarcoma Acute Myeloid Leukemia, in Relapse NPM1 Mutation Refractory AML AML With Mutated NPM1 KMT2Ar Acute Myeloid Leukemia Recurrent Mixed Lineage Leukemia Gene Mutation Nucleophosmin 1-mutated Acute Myeloid Leukemia

Summary

Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with certain genetic alterations. This protocol has 3 separate arms that will investigate the benefits and risks of adding ziftomenib to standard-of-care (SOC) drug treatments in patients who have AML with certain genetic mutations. Both newly diagnosed and relapsed refractory patients with AML will be assigned to different cohorts based on specific study criteria and physician discretion. The purpose of this study is to assess the safety, tolerability, and early signs of efficacy of ziftomenib in combination with SOC drugs to treat AML.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a new drug called ziftomenib combined with various chemotherapy regimens in patients with acute myeloid leukaemia (AML) that has a specific gene mutation — either NPM1 mutation or KMT2A rearrangement. Ziftomenib works by targeting a protein that these mutations make cancer cells dependent on. The study tests different treatment combinations depending on whether patients are newly diagnosed or have relapsed AML. **You may be eligible if...** - You have been diagnosed with AML that has either an NPM1 mutation or a KMT2A rearrangement - You are either newly diagnosed or have relapsed/refractory AML - You are in reasonably good health (ECOG 0–2) - Your liver, kidney, and heart function meet minimum thresholds **You may NOT be eligible if...** - You have acute promyelocytic leukaemia (APL) or blast crisis CML - You have active leukaemia in the brain or spinal fluid - You have a high white blood cell count that is not yet controlled - You have active HIV, hepatitis B, or hepatitis C infections - You are pregnant or breastfeeding - Your prior treatment side effects have not resolved - You have active graft-versus-host disease (GVHD) requiring significant immune suppression 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

DRUGVenetoclax

Oral Administration

DRUGAzacitidine

Subcutaneous or Intravenous Administration

DRUGDaunorubicin

Intravenous Administration

DRUGCytarabine

Intravenous Administration

DRUGQuizartinib

Oral Administration

Locations(44)

Mayo Clinic - Phoenix

Phoenix, Arizona, United States

Moores UC San Diego Cancer Center

La Jolla, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

UCLA - Bowyer Oncology Center

Los Angeles, California, United States

UC Irvine Health Chao Family Comprehensive Cancer Center

Orange, California, United States

University of Colorado

Aurora, Colorado, United States

Colorado Blood Cancer Institute

Denver, Colorado, United States

Yale Cancer Center and Smilow Cancer Hospital

New Haven, Connecticut, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, 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

University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States

The University of Kansas Medical Center Research Institute

Fairway, Kansas, United States

University of Kentucky Markey Cancer Center

Louisville, Kentucky, United States

Norton Cancer Institute - St. Matthews

Louisville, Kentucky, United States

Ochsner MD Anderson Cancer Center

Jefferson, Louisiana, United States

Johns Hopkins School of Medicine

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

UMass Chan Medical School

Worcester, Massachusetts, United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Rutgers Cancer Institute

New Brunswick, New Jersey, United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

New York - Presbyterian / Weill Cornell Medicine

New York, New York, United States

Mount Sinai - Ruttenberg Treatment Center

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

Stony Brook University Hospital

Stony Brook, New York, United States

Duke Blood Cancer Center

Durham, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Cleveland Clinic Taussig Cancer Institute

Cleveland, Ohio, United States

The James Cancer Hospital and Solove Research Institute

Columbus, Ohio, United States

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

TriStar Bone Marrow Transplant

Nashville, Tennessee, United States

Sarah Cannon Research Institute - St. David's South Austin Medical Center / Texas Oncology South Austin

Austin, Texas, United States

UT Southwestern - Simmons Cancer Center

Dallas, Texas, United States

MD Anderson Cancer Center

Houston, Texas, United States

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT05735184

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