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 SNDX-5613

What's the purpose of this trial?

Researchers are seeking the best dose of revumenib (SNDX-5613) to give with chemotherapy in people with acute myeloid leukemia (AML). The people in this study have AML that has not yet been treated. In addition, their cancers have a mutation (change) in the KMT2Ar, NPM1c, or NUP98r gene.

Revumenib works by preventing the binding of one protein to another protein. In AML, the binding of these proteins causes cancer growth. By blocking this binding, revumenib may slow the growth of your cancer.

If you join this study, you will get standard chemotherapy with cytarabine and daunorubicin or idarubicin. These drugs are given intravenously (by vein). You will also take revumenib orally (by mouth).

This trial is currently open and accepting patients.

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

To join this study, there are a few conditions. You must:

  • Have AML that has not yet been treated and has a mutation in the KMT2Ar, NPM1c, or NUP98r gene.
  • Be able to walk and do routine activities for more than half the time you are awake.
  • Be age 18 to 75.

Additional Trial Information

Phase 1

Enrollment: 76 patients (estimated)

View More
Need Help?

Interested in joining or learning more about this trial?

(888) 828-2206

Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

California

City of Hope Comprehensive Cancer Center Beckman Research Institute

Duarte, CA

Open and Accepting

UCLA Medical Center of Hematology/Oncology

Los Angeles, CA

Open and Accepting

Florida

Advent Health Cancer Institute (Orlando)

Orlando, FL

Open and Accepting

Tampa General Hospital Cancer Institute

Tampa, FL

Open and Accepting

Georgia

Winship Cancer Institute Emory University

Atlanta, GA

Open and Accepting

Illinois

University of Chicago Medicine Comprehensive Cancer Center

Chicago, IL

Open and Accepting

Kentucky

Norton Cancer Institute (St. Matthews) St. Matthews Campus

Louisville, KY

Open and Accepting

Massachusetts

Beth Israel Deaconess Medical Center

Boston, MA

Open and Accepting

Michigan

University of Michigan Comprehensive Cancer Center Rogel Cancer Center

Ann Arbor, MI

Open and Accepting

Minnesota

Abbott-Northwestern Hospital Allina Health Cancer Institute

Minneapolis, MN

Open and Accepting

New Jersey

Memorial Sloan Kettering Basking Ridge

Basking Ridge, NJ

Open and Accepting

Memorial Sloan Kettering Monmouth

Middletown, NJ

Open and Accepting

Memorial Sloan Kettering Bergen

Montvale, NJ

Open and Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Open and Accepting

Memorial Sloan Kettering Commack

Commack, NY

Open and Accepting

University of Rochester Medical Center Wilmot Cancer Center Strong Memorial Hospital

Rochester, NY

Open and Accepting

SUNY Upstate Medical University State University of New York

Syracuse, NY

Open and Accepting

Memorial Sloan Kettering Nassau

Uniondale, NY

Open and Accepting

Memorial Sloan Kettering Westchester

West Harrison, NY

Open and Accepting

North Carolina

Wake Forest Baptist - Comprehensive Cancer Center Atrium Health

Winston-Salem, NC

Open and Accepting

East Carolina University Vidant Cancer Care Eddie and Jo Allison Smith Tower

Greenville, NC

Open and Accepting

Ohio

Cleveland Clinic - Taussig Cancer Center Taussig Cancer Institute

Cleveland, OH

Open and Accepting

Oregon

Oregon Health and Science University OHSU Knight Cancer Institute

Portland, OR

Open and Accepting

Pennsylvania

UPMC Hillman Cancer Center University of Pittsburgh Medical Center (UPMC)

Pittsburgh, PA

Open and Accepting

South Carolina

MUSC Hollings Cancer Center Medical University of South Carolina

Charleston, SC

Open and Accepting

Texas

Baylor Charles A. Sammons Cancer Center Baylor Scott & White Health

Dallas, TX

Open and Accepting

MD Anderson Cancer Center The University of Texas

Houston, TX

Open and Accepting

Utah

Intermountain Healthcare - LDS Hospital Intermountain Precision Genomics Cancer Research Clinic

Salt Lake City, UT

Open and Accepting

West Virginia

WVU Cancer Institute Mary Babb Randolph Cancer Center

Morgantown, WV

Open and Accepting
Interested in this trial?
  • Call us today 😀 keyboard_arrow_right

    We know how difficult and confusing this process can be. If you are interested in this clinical trial or have questions, you can call us at any time. You can also send us a direct message with questions.

    (888) 828-2206
  • Add this trial to your favorites keyboard_arrow_right

    If you are interested in keeping an eye on this trial, you can add it to your list of favorite trials. We'll send you alerts when this trial is updated.

  • Talk to your doctor keyboard_arrow_right

    You can print an overview of this trial to take in to your next appointment. Your doctor can help you understand if this trial may be right for you.

Still need help? Send us a message