Optimizing Induction Chemotherapy Regimens for Newly Diagnosed Elderly Acute Myeloid Leukemia Patients Who Are Eligible for Intense Chemotherapy: A Multicenter, Randomized, Controlled Phase II Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Event-free survival (EFS)
研究概览
简要总结
The optimal induction chemotherapy regimen for newly diagnosed elderly AML patients who are eligible for intense chemotherapy is currently not well defined. Thus, we intend to conduct a multicenter, randomized, controlled clinical trial to screen the safety and efficacy of two induction regimens (Ven+AZA and DA/IA 2+5+VEN) in order to select one as the experimental arm in the sebsequent 3 phase RCT study. A total of 90 patients will be enrolled in this study and segregated into three groups with 30 in each group. Patients who achieve CR/CRi/CRh after using different induction regimens will receive the same consolidation and maintenance therapy. Allogeneic hematopoietic stem cell transplantation is recommended for patients in the high-risk group or those with persist MRD positivity. After completion of the treatment phase, patients entered the follow-up period.
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
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand the study and voluntarily sign informed consent.
- •Age: 60~75 years old, gender unlimited.
- •Patients diagnosed with acute myeloid leukemia according to "The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia" who haven't been treated.
- •Eastern Cooperative Oncology Group (ECOG) physical state score: 0-
- •Fit for intensive chemotherapy.
- •The function of main organs should meet the following standards before treatment: Kidney: serum creatinine ≤ 2× upper limit of normal range (ULN); Liver: total bilirubin ≤ 1.5 × ULN, AST and ALT ≤ 2.5× ULN; Heart: myocardial enzymes ≤ 2× ULN and normal ejection fraction by cardiac color doppler ultrasound
排除标准
- •Patients with acute promyelocytic leukemia
- •Patients with RUNX1::RUNX1T1 or CBFB::MYH11 fusion gene
- •Patients with BCR::ABL fusion gene
- •Patients who have received a prior treatment for AML with chemotherapy, hypomethylating agents or venetoclax before.
- •Patients with concurrent malignant tumors requiring treatment
- •Patients with active heart disease defined as one or more of the following: (1) Uncontrolled or symptomatic angina pectoris;(2) A myocardial infarction 6 months before enrolled; (3)Arrhythmia needed medication or with severe clinical symptoms;(4)Uncontrolled or symptomatic congestive heart failure (NYHA> grade 2);(5)Left ventricular ejection fraction below the lower limit of the normal range.
- •Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment
研究组 & 干预措施
DA/IA 2+5+VEN
Daunorubicin or Idarubicin ×2 days, cytarabine × 5 days combined with venetoclax as induction regimen
干预措施: Different induction chemotherapy regimens (Other)
AZA+VEN
Azacitidine combined with venetoclax as induction regimen
干预措施: Different induction chemotherapy regimens (Other)
DA/IA 3+7
Daunorubicin or Idarubicin ×3 days combined with cytarabine × 7 days as induction regimen
干预措施: Different induction chemotherapy regimens (Other)
结局指标
主要结局
Event-free survival (EFS)
时间窗: Up to approximately 2 years
It is defined as the time from the start of randomization to the occurrence of induction failure or disease progression or death from any cause (whichever occurs first).
次要结局
- Relapse-free Survival (RFS)(Up to approximately 2 years)
- Overall survival (OS)(Up to approximately 2 years)
- Minimal residual disease (MRD)-negative remission rates after induction(Up to approximately eight weeks)
- 60-day postinduction mortality(Up to approximately 60 days)
- Complete remission (CR) rate or complete remission with partial hematologic recovery (CRh) rate or complete remission with incomplete hematologic recovery (CRi) rate(Up to approximately eight weeks)
- Cumulative incidence of minimal residual disease (MRD)-negative remission rates(Up to approximately 1 years)
- 30-day postinduction mortality(Up to approximately 30 days)