RecruitingPhase 1NCT06226571

A Study of SNDX-5613 in Combination With Intensive Chemotherapy in Participants With Acute Myeloid Leukemias

A Phase 1, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of SNDX-5613 in Combination With Intensive Chemotherapy in Participants With Newly Diagnosed Acute Myeloid Leukemias Harboring Alterations in Lysine-specific Methyltransferase 2A (KMT2A/MLL), Nucleophosmin 1 (NPM1), and Nucleoporin 98 (NUP98) Genes

Sponsor

Syndax Pharmaceuticals

Enrollment

76 participants

Start Date

May 21, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemias

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of SNDX-5613 in combination with intensive chemotherapy in participants with newly diagnosed acute myeloid leukemia (AML) harboring alterations in KMT2A, NPM1, or NUP98 genes.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a drug called SNDX-5613 combined with intensive chemotherapy for adults with a type of blood cancer called Acute Myeloid Leukemia (AML) that has certain genetic mutations. **You may be eligible if...** - You have been diagnosed with AML - You have not yet received treatment for AML - Your AML has a specific genetic change: KMT2A rearrangement, NPM1 mutation, or NUP98 rearrangement - You are healthy enough to receive intensive chemotherapy - Your liver, kidney, and heart function are adequate **You may NOT be eligible if...** - You have a specific type of AML called acute promyelocytic leukemia (APL) - Your AML has spread to the fluid around your brain - You have a certain heart condition affecting your heart's electrical rhythm (prolonged QT interval) - You have already received treatment for metastatic AML 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

DRUGSNDX-5613

Participants will receive SNDX-5613 orally during Induction, Consolidation, and Maintenance until meeting criteria for discontinuation.

DRUGChemotherapy Regimen

Induction: Participants will receive an intravenous (IV), 2-drug combination of cytarabine and either daunorubicin or idarubicin.

DRUGHiDAC

Consolidation: Participants will receive HiDAC IV.

Locations(46)

UCLA Medical Hematology

Burbank, California, United States

City of Hope Medical Center

Duarte, California, United States

AdventHealth Blood & Marrow Transplant Center

Orlando, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

Emory Winship Cancer Institute

Atlanta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

University of Louisville Health Brown Cancer Center

Louisville, Kentucky, United States

Norton Cancer Institute, St. Matthews Campus

Louisville, Kentucky, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Allina Health Cancer Institute

Minneapolis, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

Institution name: Northwell Health-Brany

Lake Success, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

East Carolina University

Greenville, North Carolina, United States

Atrium Health Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Oregon Health and Science University- Center for Hematologic Malignancies

Portland, Oregon, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

MUSC Hollings Cancer Center (HCC)

Charleston, South Carolina, United States

Baylor University Medical Center

Dallas, Texas, United States

The University of Texas, MD Anderson Cancer Center

Houston, Texas, United States

LDS Hospital - Intermountain Healthcare

Salt Lake City, Utah, United States

West Virginia University

Morgantown, West Virginia, United States

Northern Hospital, Victoria

Epping, Victoria, Australia

Royal Perth Hospital

Perth, Western Australia, Australia

Royal Adelaide Hospital

Adelaide, Australia

The Alfred Hospital, Victoria

Melbourne, Australia

Sir Charles Gairdner Hospital

Nedlands, Australia

University of Alberta Hospital

Edmonton, Alberta, Canada

Gordon and Leslie Diamond Health Care Center

Vancouver, British Columbia, Canada

The Sir Mortimer B. Davis Jewish General Hospital

Montreal, Quebec, Canada

University Medical Center Utrecht

Utrecht, Netherlands

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital San Pedro de Alcantara

Cáceres, Spain

Hospital Universitario Virgen de Las Nieves

Granada, Spain

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario De Salamanca

Salamanca, Spain

Hospital Universitario Virgen del Rocio - PPDS

Seville, Spain

Universitat de Valencia

Valencia, Spain

Hammersmith Hospital

London, London, City of, United Kingdom

The Royal Marsden NHS

Sutton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06226571

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