OncoMatch/Clinical Trials/NCT05636514
Combined Evaluation of Epigenetic and Sensitising Therapy in AML and MDS
Is NCT05636514 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Decitabine/Cedazuridine 35 Mg-100 Mg ORAL TABLET and Defactinib for myelodysplastic syndromes.
Treatment: Decitabine/Cedazuridine 35 Mg-100 Mg ORAL TABLET · Defactinib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Myelodysplastic Syndrome
Acute Myeloid Leukemia
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: allogeneic stem cell transplant
Prior allogeneic stem cell transplant
Cannot have received: autologous stem cell transplant
Prior autologous stem cell transplant
Cannot have received: hypomethylating agent
Exception: ≤1 cycle allowed
Prior receipt of >1 cycle of a hypomethylating agent
Lab requirements
Blood counts
Absolute WBC ≥ 20 x 10^9/L excluded; Evidence of autoimmune hemolytic anemia (corrected reticulocyte count > 2% with either a positive DAT or >50% indirect bilirubin) excluded
Kidney function
Creatinine clearance <50 ml/min or serum creatinine ≥ 1.5 x ULN excluded
Liver function
Serum AST/SGOT or ALT/SGPT > 2.5 x ULN excluded; Serum total bilirubin > 1.5 x ULN excluded (Gilbert syndrome exception: total bilirubin < 51 umol/L upon discussion with coordinating investigator)
Cardiac function
Baseline QT interval > 440 ms (males) or 450 ms (females) excluded; Significant active cardiac disease within previous 6 months (NYHA class III/IV CHF, unstable angina, MI)
Serum AST/SGOT or ALT/SGPT > 2.5 x ULN; Serum total bilirubin > 1.5 x ULN; Creatinine clearance <50 ml/min or serum creatinine ≥ 1.5 x ULN; Absolute WBC ≥ 20 x 10^9/L; Baseline Qt interval greater than 440 milliseconds (males) or 450 milliseconds (females); Significant active cardiac disease within the previous 6 months
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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