Rutgers, The State University of New Jersey
To evaluate the 12-month relapse free survival with weekly Decitabine/cedazuridine plus Venetoclax in AML maintenance after achieving composite CR (CR, CRi, CRh)
This is an open-label, phase II, safety-primary study evaluating metronomic maintenance with once-weekly Decitabine/cedazuridine plus once-weekly Ven in patients with AML who are in CR, CRh, CRi,following standard HMAs + Ven induction and are candidates for maintenance.The study uses a single starting regimen (Venetoclax 400 mg weekly) with a pre-specified Venetoclax dose-reduction step in the event of treatment-limiting toxicity (TLT), while maintaining weekly Decitabine/cedazuridine dosing.
Inclusion Criteria: * Newly diagnosed AML (WHO 2022 classification or ICC 2022 classification) * Participants must be considered Ineligible for intensive induction defined by the following: 1. Age 75 years or older, or 2. Age 18 to 74 years with at least one of the following comorbidities: i) Severe cardiac disorder (eg, congestive heart failure requiring treatment, ejection fraction ≤50%, or chronic stable angina). ii) Severe pulmonary disorder (eg, DLCO ≤65% or FEV1 ≤65%). iii) Creatinine clearance ≥30 mL/min to \<45 mL/min iv) Moderate hepatic impairment with total bilirubin \>1.5…
Patients 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
Patients 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.
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