Overview
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.
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Acute promyeloid leukemia.
- Patients with active central nervous system (CNS) leukemia.
- Previously diagnosed with myelodysplastic syndrome (MDS) or myeloproliferative neoplasm(MPN) and progressed to AML.
- Patients with other progressive malignancies.
- Evidence of other clinically significant uncontrolled condition(s) including, but not limited to uncontrolled and/or active systemic infection (viral, bacterial or fungal).
- Patients who have participated in other trials within 30 days before signing the informed consent.
- Females who are pregnant or lactating or intending to become pregnant during the study.