Combined Evaluation of Epigenetic and Sensitising Therapy in AML and MDS
Status:
Not yet recruiting
Trial end date:
2025-12-05
Target enrollment:
Participant gender:
Summary
The goal of this project is to see if two new potential treatments (defactinib and the
combination tablet of decitabine/cedazuridine) can safely be combined to improve outcomes in
people with high-risk myelodysplastic syndrome (MDS), certain forms of Acute Myeloid
Leukaemia (AML), and Chronic Myelomonocytic Leukaemia (CMML). Decitabine/cedazuridine is
approved for use by the Australian Therapeutics Goods Administration (TGA) as treatment for
MDS. Defactinib is an experimental treatment. This means it is not an approved treatment for
MDS in Australia. So far it has been given to over 625 patients in studies across the world.
All study participants will receive active treatment, there is no placebo. Participants will
take the decitabine/cedazuridine treatment once a day for 5 days in a row (day 1 to day 5) on
its own for the first month (cycle). From month 2 participants will take the
decitabine/cedazuridine treatment and will also take the defactinib treatment, both for 5
days in a row on days 1 to day 5 each month (cycle). Defactinib is taken twice a day.
Phase:
Phase 1
Details
Lead Sponsor:
Clinical Hub for Interventional Research (CHOIR)
Collaborators:
Australian National University The University of New South Wales