A Phase I/II Study of SNDX-5613 in People with Recurrent or Persistent Acute Leukemia


Full Title

A Phase 1/2, Open-label, Dose-Escalation and Dose-Expansion Cohort Study of SNDX-5613 in Patients with Relapsed/Refractory Leukemias, Including Those Harboring an MLL/KMT2A Gene Rearrangement or Nucleophosmin 1 (NPM1) Mutation


The purpose of this study is to find the highest dose of the investigational drug SNDX-5613 that can be given safely in patients with acute leukemia that has come back or continues to grow despite treatment. SNDX-5613 stops a protein called menin from attaching to proteins called “mixed-lineage leukemia 1” (MLL1). Interactions between menin and MLL1 proteins cause leukemia to get worse. The ability of SNDX-5613 to stop these interactions may shrink or stabilize a patient’s cancer. SNDX-5613 is taken orally (by mouth).

Who Can Join

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have acute leukemia, such as acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL), that has come back or continued to grow despite treatment and cannot be cured with other therapies.
  • Patients should recover from the serious side effects of previous treatments before entering the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Eytan Stein at 212-639-3314.




Phase I/II (phases 1 and 2 combined)

Disease Status

Relapsed or Refractory



ClinicalTrials.gov ID