AZA + Venetoclax as Maintenance Therapy in Younger Adults With AML in First Remission

Korábbi kezelés

• Previously diagnosed with myelodysplastic syndrome (MDS) or myeloproliferative neoplasm(MPN) and progressed to AML.
• Patients who have participated in other trials within 30 days before signing the informed consent.

Más betegség

• 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).

Egyéb

• Acute promyeloid leukemia.
• Patients with active central nervous system (CNS) leukemia.
• Females who are pregnant or lactating or intending to become pregnant during the study.

• 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.