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Study identifier: NCT05636514 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Combined Evaluation of Epigenetic and Sensitising Therapy in AML and MDS

Condition: Myelodysplastic Syndromes · Chronic Myelomonocytic Leukemia · Acute Myeloid Leukemia  ·  Sponsor: Clinical Hub for Interventional Research (CHOIR)

PhasePhase 1
Planned participants12
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

John Pimanda, Professor  ·  1234567  ·  celestial.jcsmr@anu.edu.au

Mark Polizzotto, Professor  ·  celestial.jcsmr@anu.edu.au

Always discuss trial participation with your own doctor first.

Locations (5)

Prince of Wales HospitalSydney, New South Wales, AustraliaRecruiting
Royal Prince Alfred HospitalSydney, New South Wales, AustraliaRecruiting
Concord Repatriation and General HospitalSydney, New South Wales, AustraliaRecruiting
Nepean HospitalSydney, New South Wales, AustraliaRecruiting
Westmead HospitalWestmead, New South Wales, AustraliaRecruiting

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Source record: clinicaltrials.gov/study/NCT05636514