A Phase 1 Study of Revumenib (SNDX-5613) Plus Chemotherapy in People With Acute Myeloid Leukemia

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Full Title

A Phase 1, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of SNDX-5613 in Combination with Intensive Chemotherapy in Participants with Newly Diagnosed Acute Myeloid Leukemias Harboring Alterations in Lysine-specific Methyltransferase 2A (KMT2A/MLL), Nucleophosmin 1 (NPM1), and Nucleoporin 98 (NUP98) Genes

Purpose

Researchers are seeking the best dose of revumenib (SNDX-5613) to give with chemotherapy in people with acute myeloid leukemia (AML). The people in this study have AML that has not yet been treated. In addition, their cancers have a mutation (change) in the KMT2Ar, NPM1c, or NUP98r gene.

Revumenib works by preventing the binding of one protein to another protein. In AML, the binding of these proteins causes cancer growth. By blocking this binding, revumenib may slow the growth of your cancer.

If you join this study, you will get standard chemotherapy with cytarabine and daunorubicin or idarubicin. These drugs are given intravenously (by vein). You will also take revumenib orally (by mouth).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have AML that has not yet been treated and has a mutation in the KMT2Ar, NPM1c, or NUP98r gene.
  • Be able to walk and do routine activities for more than half the time you are awake.
  • Be age 18 to 75.

Contact

For more information or to see if you can join this study, please call Dr. Eytan Stein’s office at 646-608-3749.

Protocol

24-301

Phase

Phase I (phase 1)

Disease Status

Newly Diagnosed

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06226571