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
Sponsor: National Cancer Institute (NCI) • ClinicalTrials.gov ID: NCT05886049
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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.
Interventions
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Biospecimen Collection
(Procedure)
Undergo collection of blood
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Bone Marrow Aspiration
(Procedure)
Undergo bone marrow aspiration and biopsy
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Bone Marrow Biopsy
(Procedure)
Undergo bone marrow aspiration and biopsy
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Cytarabine
(Drug)
Given IV
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Daunorubicin
(Drug)
Given IV
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Multigated Acquisition Scan
(Procedure)
Undergo MUGA
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Revumenib
(Drug)
Given PO
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Transthoracic Echocardiography Test
(Procedure)
Undergo transthoracic ECHO
Eligibility criteria
Conditions
Locations
- UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States
- University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
- UM Sylvester Comprehensive Cancer Center at Aventura — Aventura, Florida, United States
- UM Sylvester Comprehensive Cancer Center at Coral Gables — Coral Gables, Florida, United States
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach, Florida, United States
- University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States
- UM Sylvester Comprehensive Cancer Center at Plantation — Plantation, Florida, United States
- University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
- University of Kansas Clinical Research Center — Fairway, Kansas, United States
- University of Kansas Cancer Center — Kansas City, Kansas, United States
- University of Kansas Hospital-Indian Creek Campus — Overland Park, Kansas, United States
- University of Kansas Hospital-Westwood Cancer Center — Westwood, Kansas, United States
- University of Maryland/Greenebaum Cancer Center — Baltimore, Maryland, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
- UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
- Carolinas Medical Center/Levine Cancer Institute — Charlotte, North Carolina, United States
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
- University of Cincinnati Cancer Center-UC Medical Center — Cincinnati, Ohio, United States
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
- University of Cincinnati Cancer Center-West Chester — West Chester, Ohio, United States
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
- Huntsman Cancer Institute/University of Utah — Salt Lake City, Utah, United States
- University of Virginia Cancer Center — Charlottesville, Virginia, United States
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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