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A Study of SNDX-5613 in Combination With Intensive Chemotherapy in Participants With Acute Myeloid Leukemias

Exploring SNDX-5613 with chemotherapy for acute myeloid leukemia.

Recruiting
18-75 years
All
Phase 1
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study is testing a new medicine, called SNDX-5613, with strong chemotherapy to help people with a type of blood cancer called Acute Myeloid Leukemia (AML). AML affects the blood and bone marrow. The study will test if this medicine is safe and works well. They will first find the best dose of SNDX-5613 to use with chemotherapy. Then, they will see how safe and effective it is.

Participants will go through three treatment phases: Induction (up to 2 cycles), Consolidation (up to 4 cycles, and may include a stem cell transplant if suitable), and Maintenance with SNDX-5613. Each cycle lasts 28 days. Only people with certain genetic changes in their leukemia cells, like KMT2A, NPM1, or NUP98, can join. They also need to be healthy enough for strong chemotherapy and have no other major health problems.

  • The study involves numerous cycles, each 28 days long.
  • Participants must have specific genetic changes in their AML to join.
  • There are risks and health requirements to consider before joining.
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Study details
    Acute Myeloid Leukemias

NCT06226571

Syndax Pharmaceuticals

8 March 2025

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