DSP: Phase 1/2 DSP-5336 in Acute Leukemia

Purpose of this Study

We are doing this study to find out how well an experimental drug called DSP-5336 (the study drug) works in people with AML or ALL.

Who Can Participate?

Eligibility

Adults ages 18+ who:
  • Are diagnosed with Relapsed or Refractory AML or ALL
  • Have a confirmed KMT2A (MLL)-fusion or NPM1 mutation
  • Have acceptable organ function
For more information about who can join this study, please contact the study team at 919-660-2077.

What is Involved?

Description

If you choose to join this study, you will go through a screening period to find out if you are eligible. During this screening period, you will:
  • Have a physical exam
  • Have a heart scan (ECG)
  • Have blood draws
After the screening period, this study is divided into 2 parts. In Part 1, you will be assigned to either:
  • Arm A (not taking a type of antifungal treatment); OR
  • Arm B (you are taking a type of antifungal treatment)
In Part 2, you will be assigned to either:
  • Arm A [R/R AML with Mixed Lineage Leukemia that is rearranged (MLLr AML)]; OR
  • Arm B [R/R leukemia that has the Nucleophosmin 1 gene mutated (NPM1)]
The study drug will be taken by mouth twice daily. Once you stop taking the study drug, you will enter a follow-up period. The study team will call you approximately every 3 months to see how you are feeling during this period.

Study Details

Full Title

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

Principal Investigator

Harry
Erba

Protocol Number

PRO00109316

NCT ID

NCT04988555

Phase

I/II

Enrollment Status

Open to Enrollment
ClinicalTrials.gov