A Phase 1/2, Open-Label, Dose-Escalation, Dose-Expansion Study of DSP-5336 in Adult Patients with Acute Leukemia and Other Selected Hematologic Malignancies, with and without Mixed Lineage Leukemia (MLL)-rearrangement or Nucleophosmin 1 (NPM1) Mutation


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You are being asked to participate in this study because you have acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) or leukemia of mixed lineage (the leukemia cells cannot be classified as AML or ALL or where both types of AML and ALL cells are present). Because you have already received standard therapy that is no longer helping, or there is no standard of care for your type of leukemia at this point in your care, you are eligible to participate in a study such as this that involves an experimental drug. It is up to you and your study doctor to decide on whether to take part. DSP-5336 is an experimental drug. It means that Regulatory Agencies like the Food and Drug Administration (FDA) have not approved the sale of DSP-5336 for use in patients, including in people with AML, ALL or leukemia of mixed lineage. The purpose of this study is to evaluate how safe DSP-5336 is at different doses and to find a recommended dose that is safe for further study. This study will also gain information about how your body processes the study drug over time.

Are you Eligible? (Inclusion Criteria)

  • Are you 18 years of age or older?
  • Are you able to attend study visits?
  • Have an estimated life expectancy of 3 months or greater, based on the investigator’s assessment?

Specialty Area(s)

Leukemia, Acute Lymphocytic leukemia, Acute Myeloid Leukemia

Principal Investigator

Profile Headshot
  • Director, Hematologic Malignancies Section

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032