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 with Higher-Risk Features or MLL/KMT2A Rearranged Disease

UVA Tracking #
301738
Principal Investigator
Daniel R Reed
Contact
Contact Phone
Official Trial Title
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 with Higher-Risk Features or MLL/KMT2A Rearranged Disease.
Study Description

The University of Virginia is participating in a clinical trial research study for adults ages 18 and over, who have an acute myeloid leukemia, and their cancer has a change in either a gene called NPM1 or a gene called MLL or KMT2A.

This study tests different doses of a drug called SNDX-5612 to target 1 in 5 patients who experience a severe or life-threatening side effect. This drug in combination with daunorubicin and cytarabine has not been tested in people. This study tests different doses of the drug to test the safety of the drug. There will be between 38 and 46 people taking part in this study.

Patients will receive this medication in induction and consolidation and are followed for 30 days or until participation ends.

Study-related procedure that are being done beyond your standard of care will be provided at no cost to you.

Additional information can be found here: https://clinicaltrials.gov/study/NCT05886049

uvacancertrials@hscmail.mcc.virginia.edu

Compensation

No Compensation