Daunorubicin Plus Cytarabine 3+5 Regimen Combined With Venetoclax in de Novo Patients With Acute Myeloid Leukemia: a Single Center, Open-label, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Overall response rate
研究概览
简要总结
This study is a non-profit, prospective, single-center, open-label, controlled clinical trial aimed at evaluating the efficacy of the daunorubicin, cytarabine, and venetoclax (DAV) regimen in previously untreated adult AML patients eligible for intensive chemotherapy.The combination of daunorubicin administered for 3 consecutive days and cytarabine for 7 consecutive days constitutes the classic "3+7" induction chemotherapy regimen for AML patients eligible for chemotherapy. The addition of venetoclax to the "3+7" regimen has shown promising efficacy in newly diagnosed AML patients suitable for intensive therapy. However, this approach is associated with increased adverse reactions. Based on current clinical studies, we propose a modified approach involving reduced-dose chemotherapy combined with venetoclax for AML treatment, aiming to achieve optimal efficacy while effectively reducing adverse reactions.
详细描述
PRIMARY OBJECTIVE:
- To evaluate the efficacy of the regimen, as defined by complete remission (CR), complete remission with partial hematologic recovery (CRh), complete remission with incomplete hematologic recovery (CRi), morphological leukemia-free state (MLFS), and partial remission (PR).
SECONDARY OBJECTIVES:
- To evaluate the long-term effectiveness and durability of the treatment of the regimen, as defined by 1-year overall survival (OS), 1-year event-free survival (EFS), and duration of remission (DOR).
- To evaluate the safety of the regimen, as defined by Grade 3-4 clinical adverse events (AEs), incidence of laboratory abnormalities, and treatment-related mortality (TRM).
OUTLINE:
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 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(All of the following criteria must be met.)
- •Patients with newly diagnosed AML based on FAB classification and flow cytometry standards who are eligible for intensive chemotherapy:
- •Age between 18 and 59 years;
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or 3;
- •Expected survival time of ≥3 months;
- •None of the following severe cardiac, pulmonary, hepatic, or renal conditions:
- •History of heart disease requiring treatment for congestive heart failure, or an ejection fraction ≤50%, or chronic stable angina;
- •Pulmonary diffusing capacity of carbon monoxide (DLCO) ≤65%, or forced expiratory volume in 1 second (FEV1) ≤65%;
- •Moderate liver impairment with total bilirubin >1.5 to ≤3.0 × the upper limit of normal (ULN);
- •Creatinine clearance ≥30 mL/min to <45 mL/min;
- •Has not received radiotherapy, chemotherapy, targeted therapy, or hematopoietic stem cell transplantation within 4 weeks prior to enrollment;
- •Has other comorbidities that, in the physician's judgment, make intensive chemotherapy unsuitable;
- •Is capable of understanding and willing to sign the informed consent form for this study.
排除标准
- •(Any of the following criteria will exclude the patient from participation)
- •Presence of other malignancies;
- •Prior treatment with venetoclax or azacitidine;
- •History of angioplasty or stent placement within 12 months prior to signing the informed consent, or a history of myocardial infarction, unstable angina, or other clinically significant heart disease;
- •Clinically uncontrolled active infection (including bacterial, fungal, or viral infections);
- •Pregnant or breastfeeding women;
- •Participation in any other clinical trial within 3 months prior to signing the informed consent;
- •Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study.
研究组 & 干预措施
Treatment(Daunorubicin, Cytarabine, Ventoclax)
Treatment(Daunorubicin, Cytarabine, Ventoclax) See Detailed Description.
干预措施: (Daunorubicin, Cytarabine, Venetoclax) (Drug)
Control(Daunorubicin, Cytarabine)
Control(Daunorubicin, Cytarabine) See Detailed Description.
干预措施: (Daunorubicin, Cytarabine) (Drug)
结局指标
主要结局
Overall response rate
时间窗: End of cycle 2 (each cycle is 14 days)
Defined as the proportion of patients achieving complete remission (CR), complete remission with partial hematologic recovery (CRh), complete remission with incomplete hematologic recovery (CRi), morphological leukemia-free state (MLFS), and partial remission (PR) occurring at the end of 2 cycles of treatment. Will be estimated along with the 95% credible interval. Patients who drop out of the study before completing 2 cycles and have been treated will be censored for the primary endpoint analysis.
次要结局
- Overall survival (OS)(1-Year Follow-up)
- Event-free survival (EFS)(1-Year Follow-up)
- duration of remission (DOR)(1-Year Follow-up)
- Incidence of adverse events(1-Year Follow-up)