NCT04834024招募中3 期
A Multi-center, Open Label, Phase III Study to Evaluate the Efficacy and Safety of MIL62 Plus Lenalidomide Versus Lenalidomide in Subjects With Follicular Lymphoma Refractory to Rituximab
Beijing Mabworks Biotech Co., Ltd.1 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2021年6月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Progression-free Survival (per IRC)
研究概览
简要总结
This phase III trial aims to compare the efficacy and safety of MIL62 combined lenalidomide and lenalidomide alone to treat patient diagnosed with Follicular Lymphoma (FL) and refractory to rituximab. The study randomized patients with a 1:1 ratio to receive either MIL62 plus lenalidomide or lenalidomide.
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
- •Adult patients, >=18 years of age;
- •Patients with either histologically documented CD20-positive FL, WHO grade 1, 2 or 3a
- •Evidence of refractory to rituximab
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- •At least one bi-dimensionally measurable nodal or tumor lesion defined by CT scan as: greatest transverse diameter > 1.5 cm and a short axis ≥ 10mm
- •Adequate hematologic function
- •Life expectancy >5 years
- •Able and willing to provide written informed consent and to comply with the study protocol
排除标准
- •Evidence of refractory to lenalinomide
- •Central nervous system lymphoma
- •Patients with progressive multifocalleukoencephalopathy (PML)
- •Prior use of any antibody therapy(except for Rituximab ) within 3 months of study start
- •Prior use of any anti-cancer vaccine
- •Prior administration of radiotherapy 42 days prior to study entry
- •Prior administration of chemotherapy 28 days prior to study entry
- •History of prior malignancy within the last 3 years, with the exception of curatively treated basal or squamous cell carcinoma of the skin and low-grade in situ carcinoma of the cervix
- •History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
- •Known hypersensitivity to thalidomide or lenalidomide
- •Regular treatment with corticosteroids prior to the start of cycle 1, unless administered for indications other than NHL at a dose equivalent to < 20 mg/day prednisone
- •Any serious active disease or co-morbid medical condition (such as New York Heart Association Class II or IV cardiac disease, severe arrhythmia, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm or other according to investigator's decision)
- •Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DAN or HCV RNA )
- •Pregnant or lactating females
研究组 & 干预措施
Recombinant Humanized Monoclonal Antibody MIL62, lenalinomide
Experimental
干预措施: Recombinant Humanized Monoclonal Antibody MIL62, lenalinomide (Drug)
lenalinomide
Active Comparator
干预措施: lenalinomide (Drug)
结局指标
主要结局
Progression-free Survival (per IRC)
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
次要结局
- Kaplan-Meier Estimate of Duration of Response(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)
- Percentage of Participants With Disease Control(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)
- Overall Response Rate (ORR)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)
- Progression-free Survival (per Investigator)(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)
- Overall Survival(From date of randomization Until date of death from any cause for up to 5 years)
- Number of Participants With Treatment Emergent Adverse Events(up to the 1 month the last dose of last subject)
研究者
研究点 (1)
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