Study of DSP-5336 for Treating Relapsed or Hard-to-Treat AML/ALL with or Without Specific Genetic Changes

Sponsor: Sumitomo Pharma America, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04988555

Provider View

This clinical trial is testing a new drug, DSP-5336, to see if it is safe and effective for adults with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) that has returned or is not responding to treatment. The study focuses on patients with specific genetic changes in their cancer.

Patient Parameters

Program Overview

This study is exploring a new treatment called DSP-5336 for adults with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) that has come back or is not responding to current treatments. The study is divided into two phases. Phase 1 will determine the best dose of DSP-5336 that provides the most benefit with the least side effects. Phase 2 will further test the safety and effectiveness of this dose in patients with specific genetic changes in their leukemia.

Description

The study is divided into two parts:

  • Phase 1 (Dose Escalation): This part will find the best dose of DSP-5336 that provides the most benefit with the least side effects in adults with relapsed or refractory AML, ALL, or acute leukemia of ambiguous lineage. Some patients with certain genetic changes may be prioritized for this phase.

  • Phase 2 (Dose Expansion): This part will further evaluate the safety and effectiveness of DSP-5336 in adults with relapsed or refractory AML that has specific genetic changes, such as MLL rearrangement or NPM1 mutation.

Eligibility Criteria

Exclusion Criteria

  • Heart function below a certain level.
  • Specific type of leukemia called acute promyelocytic leukemia.
  • Recent use of certain medications that affect the immune system.
  • Significant heart rhythm problems.
  • Active, uncontrolled infections.
  • Use of certain medications that interact with DSP-5336.
  • Recent use of immunotherapy or other experimental treatments.
  • Recent major surgery.
  • Active leukemia in the central nervous system.
  • Previous treatment with menin-MLL inhibitors.
  • Severe complications from leukemia.
  • Recent stem cell or CAR-T cell therapy.
  • Recent donor lymphocyte infusion or active graft-versus-host disease.
  • Recent use of certain cancer treatments.
  • High cumulative doses of certain chemotherapy drugs.
  • Other serious health conditions that could interfere with the study.
  • Active infections like HIV, hepatitis B, or hepatitis C.
  • Advanced liver disease.
  • Active autoimmune diseases requiring strong medications.
  • Other active cancers.
  • Conditions affecting the ability to take oral medications.
  • Cognitive or psychological issues affecting study participation.
  • Pregnant or breastfeeding women, or those planning to become pregnant.
  • History of certain lung diseases (for sites in Japan only).
  • History of a specific heart rhythm disorder called Torsades de Pointes.

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