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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Relapse-free survival (RFS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 =
- •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.
排除标准
- •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.
研究组 & 干预措施
Treatment (azacytidine+venetoclax)
Participants will receive azacytidine QD, on Days 1-5 and venetoclax QD, on Days 1-14 of each 28-day cycle for 8 cycles.
干预措施: Azacitidine (Drug)
Treatment (azacytidine+venetoclax)
Participants will receive azacytidine QD, on Days 1-5 and venetoclax QD, on Days 1-14 of each 28-day cycle for 8 cycles.
干预措施: Venetoclax (Drug)
Treatment (azacytidine+venetoclax)
Participants will receive azacytidine QD, on Days 1-5 and venetoclax QD, on Days 1-14 of each 28-day cycle for 8 cycles.
干预措施: Supportive care (Other)
Comparator ( best supportive care)
Participants will receive observation and supportive care during remission.
干预措施: Supportive care (Other)
结局指标
主要结局
Relapse-free survival (RFS)
时间窗: From date of complete remission (CR) or complete remission with incomplete count recovery (CRi), to relapse or death from any cause, up to approximately 3 years
RFS is defined as the number of days from CR/CRi to the date of relapse or the date of death from any cause, whichever comes first.
次要结局
- Incidence of adverse events(Time from treatment to approximately 3 years)
- Complete remission duration (CRd)(From date of CR/CRi to approximately 3 years)
- Overall Survival (OS)(Time from treatment to death from any cause, up to approximately 3 years)
- Event free survival (EFS)(Time from treatment to relapse，withdrawal from study due to adverse event and death from any cause, up to approximately 3 years)
- Percentage of Participants Who Achieve Minimal Minimal Residual Disease (MRD) Negative Conversion(Measured From Baseline to approximately 3 years)
研究者
Chen Suning
Principal Investigator
The First Affiliated Hospital of Soochow University