A Randomized, Double-blind Phase 3 Study of Vadastuximab Talirine (SGN-CD33A) Versus Placebo in Combination With Azacitidine or Decitabine in the Treatment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Seagen Inc.
- 入组人数
- 240
- 试验地点
- 128
- 主要终点
- Overall Survival
研究概览
简要总结
The purpose of this study in AML patients is to test whether vadastuximab talirine (SGN-CD33A; 33A) combined with either azacitidine or decitabine improves remission rates and extends overall survival as compared to placebo combined with either azacitidine or decitabine.
详细描述
Hypomethylating agents (HMAs), such as decitabine or azacitidine, are considered a standard treatment for older patients with AML. The primary goals of this study are to test whether patients treated with an HMA (either decitabine or azacitidine) in combination with 33A will have better anti-tumor activity and/or survive longer than patients treated with an HMA in combination with placebo.
Patients who meet eligibility criteria will be randomly assigned to one of two treatment groups: 1) 33A plus HMA (Experimental Arm); or 2) placebo plus HMA (Comparator Arm). In addition to evaluating survival and remission rates, the minimal residual disease (MRD)-negative remission rate, duration of remission, event free- and leukemia-free survival, and safety and tolerability will be compared between arms.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed, previously untreated, cytologically/histologically confirmed de novo or secondary AML according to World Health Organization (WHO) classification (except for acute promyelocytic leukemia (APL))
- •Intermediate or adverse cytogenetic risk
- •Eligible for therapy with either decitabine or azacitidine
- •Acceptable hematologic and organ function
排除标准
- •AML associated with favorable risk karyotypes including inv(16), t(8;21), t(16;16), or t(15;17)
- •Patients who are candidates for allogeneic stem cell transplant at the time of enrollment
- •Patients with a history of one of the following myeloproliferative neoplasms: essential thrombocythemia, polycythemia vera, and primary myelofibrosis
- •Received prior treatment with HMA or chemotherapy for antecedent myelodysplastic syndrome (MDS)
研究组 & 干预措施
placebo + HMA
placebo plus azacitidine or decitabine
干预措施: placebo (Drug)
33A + HMA
33A plus azacitidine or decitabine
干预措施: 33A (Drug)
33A + HMA
33A plus azacitidine or decitabine
干预措施: azacitidine (Drug)
33A + HMA
33A plus azacitidine or decitabine
干预措施: decitabine (Drug)
placebo + HMA
placebo plus azacitidine or decitabine
干预措施: azacitidine (Drug)
placebo + HMA
placebo plus azacitidine or decitabine
干预措施: decitabine (Drug)
结局指标
主要结局
Overall Survival
时间窗: Up to 1.5 years
Time from randomization to death due to any cause
Composite Complete Remission (CRc) Rate
时间窗: Up to 1.5 years
Number of patients who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) according to the modified response criteria for acute myeloid leukemia (AML) per Cheson 2003.
次要结局
- Minimal Residual Disease (MRD)-Negative Composite Complete Remission Rate(Up to 1.5 years)
- Event-free Survival(Up to approximately 11.24 months)
- Duration of Remission(Up to approximately 9.5 months)
- Leukemia-free Survival(Up to approximately 9.49 months)
- Incidence of Grade 3 or Higher Laboratory Abnormalities(Up to 1.5 years)
- Time to Complete Remission(Up to 1.5 years)
- Type, Incidence, Severity, Seriousness, and Relatedness of Adverse Events(Up to 1.5 years)
- Mortality Rates at Day 30 and Day 60(Up to 60 days)