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Study identifier: NCT05886049 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

A Phase 1b Study of Menin Inhibitor SNDX- 5613 in Combination With Daunorubicin and Cytarabine in Newly Diagnosed Patients With Acute Myeloid Leukemia and NPM1 Mutated/FLT3 Wildtype or MLL/KMT2A Rearranged or NUP98 Alterations Disease

Condition: Acute Myeloid Leukemia · Acute Myeloid Leukemia With KMT2A Rearrangement · Acute Myeloid Leukemia With NPM1 Mutation  ·  Sponsor: National Cancer Institute (NCI)

PhasePhase 1
Planned participants38
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNo

About this study

This phase Ib trial tests the safety, side effects, and best dose of SNDX-5613 when given in combination with the standard chemotherapy treatment (daunorubicin and cytarabine) in treating patients with newly diagnosed acute myeloid leukemia that has changes in the NPM1 gene or MLL/KMT2A gene. SNDX-5613 blocks signals passed from one molecule to another inside cancer cells that are needed for cancer cell survival. Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding SNDX-5613 to the standard chemotherapy treatment may be able to shrink or stabilize the cancer for longer than the standard chemotherapy treatment alone.

This description comes directly from the study's public registry record.

Talk to the study team

Contact details are listed per location below or on the registry record.

Always discuss trial participation with your own doctor first.

Locations (22)

UC Irvine Health/Chao Family Comprehensive Cancer CenterOrange, California, United StatesRecruiting
University of California Davis Comprehensive Cancer CenterSacramento, California, United StatesSuspended
UM Sylvester Comprehensive Cancer Center at AventuraAventura, Florida, United StatesRecruiting
UM Sylvester Comprehensive Cancer Center at Coral GablesCoral Gables, Florida, United StatesRecruiting
UM Sylvester Comprehensive Cancer Center at Deerfield BeachDeerfield Beach, Florida, United StatesRecruiting
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, Florida, United StatesRecruiting
UM Sylvester Comprehensive Cancer Center at PlantationPlantation, Florida, United StatesRecruiting
University of Chicago Comprehensive Cancer CenterChicago, Illinois, United StatesRecruiting
University of Kansas Clinical Research CenterFairway, Kansas, United StatesRecruiting
University of Kansas Cancer CenterKansas City, Kansas, United StatesRecruiting
University of Kansas Hospital-Indian Creek CampusOverland Park, Kansas, United StatesRecruiting
University of Kansas Hospital-Westwood Cancer CenterWestwood, Kansas, United StatesRecruiting

+ 10 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05886049