To evaluate the 12-month relapse free survival with weekly Decitabine/cedazuridine plus Venetoclax in AML maintenance after achieving composite CR (CR, CRi, CRh)
Newly diagnosed AML (WHO 2022 classification or ICC 2022 classification)
Age 75 years or older, or
Must have achieved CR,CRh, CRi, following induction with maximum 3 cycles of standard IV HMAs and venetoclax.
Able to provide informed consent
Progression or relapse after induction standard HMAs + Venetoclax therapy
Pregnancy or breastfeeding
Uncontrolled infection, active CNS disease, or concurrent malignancy requiring systemic therapy
Inability to take oral medication or presence of malabsorption syndrome or any other uncontrolled gastrointestinal condition
Single group
Venetoclax, Decitabine/Cedaruridine
DrugPatients who consent to the study will receive weekly Decitabine/Cedaruridine plus Venetoclax until intolerance or disease progression. Both Decitabine/Cedaruridine and Venetoclax are administered orally once on D1, 8, 15, 22 each
decitabine/cedazuridine
DrugPatients who consent to the study will receive weekly decitabine/cedazuridine plus Venetoclax until intolerance or disease progression. Venetoclax is administered orally once on D1, 8, 15, 22 each 28-day cycle with food and water. Decitabine/Cedazuridine is administered orally once on D1, D8, D15 D22 with empty stomach.
Primary Outcome
To evaluate the relapse free survival in patients with AML receiving metronomic maintenance therapy with weekly Decitabine/cedazuridine plus Venetoclax. RFS is measured from the date of first documented CR/CRi until the date of confirmed relapse or death from any cause, whichever occurs first.
Secondary Outcome 1
To assess treatment delay defined as postponing treatment for more than 7 days or cancellation of treatment due to adverse effects caused by maintenance chemotherapy.
Secondary Outcome 2
To determine the overall survival, defined as the number of days from the start of induction therapy to the date of death. Subjects that have not died will be censored at the last known date to be alive.
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