RecruitingPhase 1NCT05636514

Combined Evaluation of Epigenetic and Sensitising Therapy in AML and MDS

A Phase I Study of Oral Decitabine and Cedazuridine (ASTX727) In Combination With Defactinib (VS-6063) as Therapy of Myelodysplastic Syndromes and Low-blast Acute Myeloid Leukaemia

Sponsor

Clinical Hub for Interventional Research (CHOIR)

Enrollment

12 participants

Start Date

Dec 14, 2022

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia Myelodysplastic Syndromes Chronic Myelomonocytic Leukemia

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a combination of epigenetic therapy (drugs that change how genes are switched on or off) alongside other treatments in people with a pre-leukemia condition called myelodysplastic syndrome (MDS) or early acute myeloid leukemia (AML). These are blood and bone marrow disorders. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with intermediate-high or high-risk MDS, or AML with 20–30% marrow blasts and evidence of dysplasia - You are not eligible for or have refused standard intensive chemotherapy **You may NOT be eligible if...** - You have a different type of leukemia or blood disorder - Your MDS is classified as low or intermediate-1 risk - You are eligible for and willing to receive standard intensive chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDecitabine/Cedazuridine 35 Mg-100 Mg ORAL TABLET

Fixed dose treatment cycles 1 to 6. Cycle 1 is monotherapy, cycles 2 to 6 combination therapy with defactinib.

DRUGDefactinib

Defactinib treatment will commence with at the starting dose (dose level 1) from cycle 2 to 6. Dose escalation/de-escalation will proceed based on the MTD determination. Dose Level 1: 200mg Defactinib twice daily (starting dose level) Dose Level 2: 400mg defactinib twice daily Dose Level -1: 200mg Defactinib daily

Locations(5)

Prince of Wales Hospital

Sydney, New South Wales, Australia

Royal Prince Alfred Hospital

Sydney, New South Wales, Australia

Concord Repatriation and General Hospital

Sydney, New South Wales, Australia

Nepean Hospital

Sydney, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

View Full Details on ClinicalTrials.gov

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NCT05636514

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