NCT07028086招募中2 期
Prospective, Multicenter, Single-Arm Clinical Study of Mitoxantrone Liposome Combined With Azacitidine and Venetoclax in the Treatment of Secondary AML, AML With Extramedullary Involvement, and Myeloid Sarcoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Composite Complete Remission Rate
研究概览
简要总结
The mitoxantrone liposomal enhances the tissue permeability of mitoxantrone by incorporating liposomal groups compared to the conventional mitoxantrone formulation, while also reducing the concentration of free mitoxantrone, thereby minimizing drug side effects-particularly cardiotoxicity.
Building upon this, the investigators aim to investigate the efficacy and safety of the liposomal mitoxantrone hydrochloride injection in patients with secondary AML, AML with extramedullary involvement, or myeloid sarcoma, in order to explore alternative therapeutic strategies for these populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient fully understands this study, voluntarily participates, and signs the informed consent form (ICF)
- •Age 18-65 years
- •Clinically diagnosed, previously untreated acute myeloid leukemia (non-APL), meeting any one of the following criteria: a. Secondary acute myeloid leukemia; b. Therapy-related acute myeloid leukemia; c. AML with extramedullary/myeloid sarcoma; d. Age ≥60 years, assessed as fit-AML;
- •Normal cardiac function, with left ventricular ejection fraction (LVEF) ≥50%
- •Liver and kidney function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal (ULN) (≤5 times ULN for patients with liver involvement); total bilirubin ≤1.5 times ULN; serum creatinine ≤1.5 times ULN
- •Eastern Cooperative Oncology Group (ECOG) performance status score: 0-2
排除标准
- •Assessed as unfit- or frail-AML;
- •Patients with a history or concurrent diagnosis of other malignancies requiring treatment
- •Uncontrolled systemic diseases (e.g., advanced active infections, uncontrolled hypertension, etc.)
- •Known history of immediate or delayed hypersensitivity reactions to the same class of study drugs or excipients
- •Pregnant or breastfeeding women, or patients who refuse to use effective contraception during the study period
- •Patients with a history of severe neurological or psychiatric disorders
- •Other severe medical conditions, such as myocardial infarction, severe or unstable angina, severe arrhythmias
- •Cerebrovascular events (including transient ischemic attacks), etc.
- •Known infection with human immunodeficiency virus (HIV); active hepatitis B or C infection; inactive hepatitis carriers or subjects with low viral titers after receiving non-prohibited antiviral therapy are not excluded
- •Subjects who have received strong or moderate CYP3A inducers/inhibitors or strong P-gp inhibitors or related foods within 7 days before starting the study treatment
- •Patients unable to take oral medications or with malabsorption syndrome
- •Patients deemed by the investigator to be unsuitable for participation in the study
研究组 & 干预措施
MAVEN_GROUP
Experimental
干预措施: VAM_GROUP (Drug)
结局指标
主要结局
Composite Complete Remission Rate
时间窗: After completing two cycles (each cycle is 28 days) of VAM therapy
次要结局
- Event-Free Survival(from data of AML diagnosis until the data of events, assessed up to 2 years)
- Overall Survival(from enrollment to study completion, a maximum of 2 years)
- Safety: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(During the two cycles (each cycle is 28 days) of VAM therapy and follow-up for 2 years after completion)
研究者
研究点 (1)
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