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.
- 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?
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.
- 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
Harry
Erba
Protocol Number
PRO00109316
NCT ID
NCT04988555
Phase
I/II
Enrollment Status
OPEN TO ACCRUAL