NCT04578613招募中3 期
A Randomized, Controlled, Open, Multicenter Phase 3 Study to Evaluate ICP-022 Versus Chlorambucil Combined With Rituximab for Primary Treatment of Chronic Lymphocytic Leukemia(CLL)/ Small Lymphocytic Lymphoma(SLL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 218
- 试验地点
- 56
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
This is a randomized, multicenter, open-label, Phase 3 study to evaluate the efficacy and safety of ICP-022 versus Chlorambucil plus Rituximab in subjects with Previously Untreated Chronic Lymphocytic Leukemia.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age ≥65 years old or age >18 years old or <65 years old, age >18 years old or <65 years old shall meet any of the following criteria simultaneously: A.Disease accumulation score (CIRS) > 6;B. Creatinine clearance at 30-69 mL/ min (Cockcroft-Gault assessment)
- •Enhanced computed tomography/magnetic resonance imaging (CT/MRI) detection had measurable lesions: at least one lymph node had a maximum axis of more than 1.5 cm and had a measurable vertical dimension
- •ECOG physical strength score is 0-
- •Expected survival time >6 months.
- •Voluntary written informed consent prior to screening.
排除标准
- •Patients with stroke or intracranial hemorrhage in the first 6 months were randomly assigned.
- •Hypersensitivity to ICP-022, nitrogen mustard benzoate, rituximab or any other component of the applicable study drug.
- •Any mental or cognitive impairment that may limit their understanding of the informed consent, their implementation and their compliance with the study.
- •Pregnant and lactating women, or subjects of childbearing age who do not want to use contraception within 180 days from the end of the study period to the end of the study period.
- •Conditions in which a potentially life-threatening illness or severe organ dysfunction is not considered appropriate by the investigator.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
ICP-022
Experimental
ICP-022 will be orally administered until disease progression or unacceptable toxicity.
干预措施: ICP-022 (Drug)
Chlorambucil combined with Rituximab
Active Comparator
Chlorambucil orally administered and Rituximab via IV infusion for 6 cycles.
干预措施: Chlorambucil (Drug)
Chlorambucil combined with Rituximab
Active Comparator
Chlorambucil orally administered and Rituximab via IV infusion for 6 cycles.
干预措施: Rituximab (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Up to 5 years
Progress-free survival (PFS) was evaluated by the independent review board (IRC) against the IWCLL2018 criteria (Hallek et al., 2018) and the revised lymphoma mitigation assessment criteria (Cheson et al., 2014).
次要结局
- Duration Of Response (DOR)(Up to 5 years)
- Overall Survival (OS)(Up to 5 years)
- Objective Response Rate (ORR)(Up to 5 years)
研究者
研究点 (56)
Loading locations...
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