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
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18-75 lat w momencie rozpoznania
- •Nowo rozpoznana ostra białaczka szpikowa, która nie była jeszcze leczona
- •Określone zmiany genetyczne (mutacja NPM1, zmiana MLL/KMT2A lub zmiana NUP98)
- •Pacjent powinien być w stanie znośnie funkcjonować i podejmować intensywne leczenie chemiczne
- •Prawidłowe funkcje wątroby i nerek
- •Pacjenci z HIV na skutecznym leczeniu z niedetektowalnym wirusem są dopuszczeni
✗ Disqualifies
- •Poniżej 18 lat (brak danych bezpieczeństwa u dzieci)
- •Pacjenci, którzy wcześniej otrzymali chemioterapię na białaczkę
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Last updated (source)
- July 20, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (22)
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, United States
University of California Davis Comprehensive Cancer Center
Sacramento, United States
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, United States
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, United States
University of Chicago Comprehensive Cancer Center
Chicago, United States
University of Kansas Clinical Research Center
Fairway, United States
University of Kansas Cancer Center
Kansas City, United States
University of Kansas Hospital-Indian Creek Campus
Overland Park, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, United States
Wake Forest University Health Sciences
Winston-Salem, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, United States
Ohio State University Comprehensive Cancer Center
Columbus, United States
University of Cincinnati Cancer Center-West Chester
West Chester, United States
University of Oklahoma Health Sciences Center
Oklahoma City, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, United States
University of Virginia Cancer Center
Charlottesville, United States
Trial contact
Site Public Contact
Kiran Naqvi
PRINCIPAL_INVESTIGATOR
Site Public Contact
Sangeetha Venugopal
PRINCIPAL_INVESTIGATOR
Site Public Contact
Site Public Contact
Olatoyosi M. Odenike
PRINCIPAL_INVESTIGATOR
Site Public Contact
Jesus Gonzalez Lugo
PRINCIPAL_INVESTIGATOR
Site Public Contact
Vu H. Duong
PRINCIPAL_INVESTIGATOR
Site Public Contact
Joshua F. Zeidner
PRINCIPAL_INVESTIGATOR
Site Public Contact
Brittany K. Ragon
PRINCIPAL_INVESTIGATOR
Site Public Contact
Matthew J. Wieduwilt
PRINCIPAL_INVESTIGATOR
Site Public Contact
Emily K. Curran
PRINCIPAL_INVESTIGATOR
Site Public Contact
Alice S. Mims
PRINCIPAL_INVESTIGATOR
Site Public Contact
Mohamad Khawandanah
PRINCIPAL_INVESTIGATOR
Site Public Contact
Paul J. Shami
PRINCIPAL_INVESTIGATOR
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/17/2026.
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