New combo therapy aims to improve AML treatment for patients with specific gene changes

NCT ID NCT05886049

Recruiting now Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 21, 2026 · Updated 4 times

Summary

This early-phase trial tests whether adding a menin inhibitor (SNDX-5613) to standard chemotherapy can better control acute myeloid leukemia (AML) in people with certain gene changes (NPM1 or MLL). About 38 newly diagnosed adults will receive the combination to find the safest dose and check for side effects. The goal is to see if the targeted drug helps shrink or stabilize the cancer longer than chemo alone.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia acute myeloid leukemia with mutated NPM1 acute myeloid leukemia, MLL gene rearrangement therapy related acute myeloid leukemia and myelodysplastic syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ACUTE MYELOID LEUKEMIA ACUTE MYELOID LEUKEMIA WITH KMT2A REARRANGEMENT ACUTE MYELOID LEUKEMIA WITH NPM1 MUTATION SECONDARY ACUTE MYELOID LEUKEMIA

Contacts and locations

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Locations

Carolinas Medical Center/Levine Cancer Institute
RECRUITING

Charlotte, North Carolina, 28203, United States
Huntsman Cancer Institute/University of Utah
RECRUITING

Salt Lake City, Utah, 84112, United States

Contact Email: •••••@•••••
Ohio State University Comprehensive Cancer Center
RECRUITING

Columbus, Ohio, 43210, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
RECRUITING

Orange, California, 92868, United States

Contact Email: •••••@•••••
UM Sylvester Comprehensive Cancer Center at Aventura
RECRUITING

Aventura, Florida, 33180, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables
RECRUITING

Coral Gables, Florida, 33146, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
RECRUITING

Deerfield Beach, Florida, 33442, United States
UM Sylvester Comprehensive Cancer Center at Plantation
RECRUITING

Plantation, Florida, 33324, United States
UNC Lineberger Comprehensive Cancer Center
RECRUITING

Chapel Hill, North Carolina, 27599, United States

Contact Email: •••••@•••••
University of California Davis Comprehensive Cancer Center
SUSPENDED

Sacramento, California, 95817, United States
University of Chicago Comprehensive Cancer Center
RECRUITING

Chicago, Illinois, 60637, United States

Contact Email: •••••@•••••
University of Cincinnati Cancer Center-UC Medical Center
RECRUITING

Cincinnati, Ohio, 45219, United States

Contact Email: •••••@•••••
University of Cincinnati Cancer Center-West Chester
RECRUITING

West Chester, Ohio, 45069, United States

Contact Email: •••••@•••••
University of Kansas Cancer Center
RECRUITING

Kansas City, Kansas, 66160, United States
University of Kansas Clinical Research Center
RECRUITING

Fairway, Kansas, 66205, United States
University of Kansas Hospital-Indian Creek Campus
RECRUITING

Overland Park, Kansas, 66211, United States
University of Kansas Hospital-Westwood Cancer Center
RECRUITING

Westwood, Kansas, 66205, United States
University of Maryland/Greenebaum Cancer Center
RECRUITING

Baltimore, Maryland, 21201, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
RECRUITING

Miami, Florida, 33136, United States
University of Oklahoma Health Sciences Center
RECRUITING

Oklahoma City, Oklahoma, 73104, United States
University of Virginia Cancer Center
ACTIVE_NOT_RECRUITING

Charlottesville, Virginia, 22908, United States
Wake Forest University Health Sciences
RECRUITING

Winston-Salem, North Carolina, 27157, United States

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