Daiichi Sankyo DS3201-A-U102 Phase 1 DS-3201b in AML and ALL - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out what dosage of the study drug, DS-3201b, will be safe and will work to treat acute leukemia.

What is the Condition Being Studied?

Acute Myeloid Leukemia (AML) or Acute Lymphocytic Leukemia (ALL)

Who Can Participate in the Study?

Adults who:
- Have AML that has failed any prior therapy
- Have adequate organ function (kidney, liver)
- Have stopped other therapy at least 2 weeks before starting study treatment
- Do not have central nervous system involvement of leukemia
- Do not have an active cancer under active treatment
- Do not have an uncontrolled infection

Age Group

What is Involved?

If you choose to join this study, you will:
- Have a screening visit to make sure it is safe for you to be in this study.
- Take the study drug, DS-3201b, by mouth once a day every day for 28 days
- Have follow-up visits that will include physical exams and other tests for up to 2 years

Study Details

Full Title
A Phase 1 Study of DS-3201b in Subjects with Acute Myelogenous Leukemia (AML) or Acute Lymphocytic Leukemia (ALL)
Principal Investigator
Cell Therapy and Hematologic Malignancies Specialist
Protocol Number
IRB: PRO00100447
NCT: NCT03110354
Phase I
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center