A multicenter, single arm, non-randomised Phase IIA Study to evaluate ASLAN003 as a monotherapy in patients with AML.


Acute Myeloid Leukaemia


The bone marrow is like a factory, producing all types of blood cells. This process begins with immature stem cells in the bone marrow, and results in production of mature red cells, platelets and different types of white cells.

Acute myeloid leukaemia (AML) is an aggressive cancer of the bone marrow. In AML, there is an overproduction of immature white cells, known as blasts. These immature cells do not function properly to prevent and fight infection, and can result in production of inadequate numbers of red cells and platelets, which in turn may lead to anaemia, bleeding and bruising.

There are range of chemotherapy options available to treat AML, but these are not suitable for everybody, (for example due to other medical problems), and there may be situations where these treatments do not work, or where the leukaemia comes back having previously been successfully treated.

There are new drugs being developed that target a range of cell pathways involved in the development of AML. One of these groups of drugs works by inhibiting an enzyme known as DHODH, which in turn promotes the normal maturation process of the excess immature white cells found in AML.

The aim of this study is to understand the safety and effectiveness of the DHODH inhibitor ASLAN003 as a single agent in patient with AML.


Include, but not limited to, the following:

Includes, but not limited to, the following:

1) Patients with AML (except for a subtype called APML – Acute Promyelocytic Leukaemia), in one of the following categories:
a. Newly diagnosed AML, for whom standard treatments are not felt to be suitable.
b. AML that has returned, having previously been treated successfully.
c. AML that has not responded to previous treatment, including chemotherapy or a stem cell transplant.
2) No other serious health conditions
3) No history of other cancers, unless in remission for over 12 months (except for some localised skin cancers that may have been cured with a minor operation)

Contact person:

Lewis Edwards, Clinical Trials Co-ordinator, Linear Clinical Research
Phone 6382 5125


Principal Investigator:

Dr Carolyn Grove


Aslan Pharmaceuticals



Protocol Number:


Trial Registration Number:


ANZ Clinical Trial Registry