Aptose_HM-FLTI-101 (Acute Myeloid Leukemia) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if an investigational drug called HM43239 (the study drug) is a safe and effective option for people who have AML that came back after remission or did not respond to standard treatments. We also want to find out what dose of the study drug works best for most patients.

What is the Condition Being Studied?

Acute Myeloid Leukemia (AML)

Who Can Participate in the Study?

Adults ages 18+ who:

- Are diagnosed with AML

- Did not respond to previous treatment or had their cancer come back after going into remission with previous therapy

- Have not gotten any chemotherapy drugs for at least 2 weeks or immunotherapy drugs for at least 4 weeks before starting the study regimen

For more information about who can join this study, please contact the study team at peggy.alton@duke.edu or 919-684-9220.

Age Group

What is Involved?

If you choose to join this study, you will take the study drug every day. If you enroll in a later stage of the study, you will take a drug called Venetoclax every day in addition to the study drug. The dose of the study drug that you get and whether or not you take the study drug in combination with Venetoclax will depend on when you join the study.

Both the study drug and Venetoclax are pills that you take by mouth. You will continue to take the study regimen for as long as you and the study doctor believe that you are benefitting.

Study Details

Full Title
Aptose: A Phase 1/2, Open-label, Multicenter, Dose Escalation and Expansion Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM43239 in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)
Principal Investigator
Hematologic Oncologist
Protocol Number
IRB: PRO00111705
NCT: NCT03850574
Phase I/II
Enrollment Status
Open for Enrollment