A Phase 3, Randomised, Parallel-group, Active-controlled, Double-blind Study to Compare Efficacy and Safety Between CT-P10 and Rituxan in Patients With Low Tumour Burden Follicular Lymphoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Celltrion
- 入组人数
- 258
- 试验地点
- 1
- 主要终点
- Primary Efficacy Endpoint - Overall Response Rate by 7 Months
研究概览
简要总结
To demonstrate that CT-P10 is similar to Rituxan in terms of efficacy as determined by overall response rate at 7 months
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
- •Confirmed diagnosis of low tumour burden, CD20+ follicular lymphoma
- •Ann Arbor Stage II, III or IV
排除标准
- •Has receive rituximab
- •Allergies or hypersensitivity to murine, chimeric, human or humanised proteins
- •Previous treatment for NHL
- •Any malignancy
- •Current or recent treatment with any other investigational medicinal product or device
- •pregnant or lactating
结局指标
主要结局
Primary Efficacy Endpoint - Overall Response Rate by 7 Months
时间窗: During the Month 7 (up to Maintenance Cycle 3; Week 28)
ORR was defined as the proportion of patients with the best response of complete response (CR), unconfirmed CR (CRu), or partial response (PR) by central review. Per 1999 IWG criteria, the disease status was assessed by using contrasted CT and/or MRI, and CR, CRu, and PR were defined as followings; CR=Disappearance of all clinical/radiographic evidence of disease: regression of lymph nodes to normal size, absence of B-symptoms, bone marrow involvement, and organomegaly, and normal LDH level; CRu=Regression of measurable disease: \>75% decrease in SPD of target lesions and in each target lesions. no increase in the size of non-target lesions, neither new lesion nor organomegaly measured; PR=Regression of measurable disease: ≥50% decrease in SPD of target lesions and no evidence of disease progression.
次要结局
- Secondary Efficacy Endpoint - Overall Survival (OS)(Overall study period (median follow-up of 29.2 months))
- Secondary Efficacy Endpoint - ORR Over the Study Period(up to 27 months)
- Secondary PK Endpoints - Ctrough(1, 2, 3, 4, 12, 20 weeks (predose, 1 hr post dose), EOT1/EOT2 (anytime during the day) and 28 week (predose))
- Secondary PD Endpoint - B-cell Kinetics (B-cell Depletion and Recovery)(Baseline, Induction Cycle 1 (predose, 1 hr postdose), Induction Cycle 2 to 4 (predose), EOT1/EOT2 (anytime), Maintenance Cycle 1 to 2 (predose, 1hr postdose) and Maintenance Cycle 3 (predose).)
- Secondary PK Endpoints - Cmax(1, 2, 3, 4, 12, 20 weeks (predose, 1 hr post dose), EOT1/EOT2 (anytime during the day) and 28 week (predose))
- Secondary Efficacy Endpoint - Progression-free Survival (PFS)(Overall study period (Baseline, Month 3, 7, 13, 19 27, and every 6 months thereafter).)
- Secondary Efficacy Endpoint - Time-to Progression (TTP)(Overall study period (Baseline, Month 3, 7, 13, 19 27, and every 6 months thereafter).)