DSP: Phase 1/2 DSP-5336 in Acute Leukemia with or with MLL or NPM1 mutation - Clinical Trial

What is the 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.

What is the Condition Being Studied?

Mixed Lineage Leukemia (MLL) Rearrangement or Nucleophosmin 1 (NPM1) Mutation

Who Can Participate in the Study?

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.

Age Group

What is Involved?

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)

-- 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)]

-- 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
Hematologic Oncologist
Protocol Number
IRB: PRO00109316
NCT: NCT04988555
Phase I/II
Enrollment Status
Open for Enrollment