Randomized, Multicenter, Phase 3 Study of Azacytidine (AZA) + Venetoclax as Maintenance Therapy in Patients With AML in Remissionin Younger Adults With Favorable-risk AML in First Remission After Conventional Chemotherapy
This phase III trial is conducted to evaluate if azacitidine in combination with venetoclax as maintenance therapy improves relapse-free survival (RFS) for younger adults with favorable-risk acute myeloid leukemia (AML) who remained in first complete remission (CR1) following intensive consolidation.
• Diagnosis of favorable-risk acute myeloid leukemia (AML) according to revised 2017 European LeukemiaNet genetic risk stratification and are not immediate candidates for allogeneic stem cell transplant.
• Aged 18-64 years.
• Patients who have received remission induction therapy and 3-4 HiDAC or medium-dose cytarabine-based consolidation and are in their first remission.
• ECOG performance status of \< or = 3.
• Adequate organ function as follows:
‣ Serum total bilirubin \< or = to 3 X the Upper Limit of Normal (ULN)
⁃ Aspartate Transaminase and alanine transaminase \< or = to 3 x ULN
⁃ Ccr（Creatinine Clearance Rate) \> or ＝60 ml/min
⁃ Left ventricular ejection fraction \> or ＝50% determined by ultrasound.
• For females of childbearing age, they should have a negative serum or urine pregnancy test within 10 to 14 days of enrolling.
• For males of childbearing age, they should take effective contraceptive methods throughout the treatment period and up to 30 days after discontinuing treatment.
• Ability to understand and sign informed consent.