NCT03289182已完成不适用
Post-Marketing Surveillance of MabThera Subcutaneous in Patients With Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 701
- 试验地点
- 25
- 主要终点
- Percentage of Participants with Adverse Events
研究概览
简要总结
This is a prospective, multicenter, non-interventional study to test the safety and effectiveness of MabThera administered subcutaneously in participants with NHL or CLL. The length of study is expected to be 6 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants administered with MabThera subcutaneously within the approved indication in Korea
- •Participants previously untreated with MabThera subcutaneously
- •Inclusion Criteria for NHL participants for MabThera subcutaneously 1400mg:
- •Relapsed or chemoresistant follicular lymphoma (FL) (B, C, and D type by international working formulation classification of B-cell NHL) participants
- •Previously untreated FL participants in combination with chemotherapy
- •Participants who are treated with maintenance therapy after the treatment of FL participants responding to induction therapy.
- •Cluster of differentiation 20-positive, diffuse large B-cell NHL participants in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone (8 cycles) chemotherapy
- •Inclusion Criteria for CLL participants for MabThera subcutaneously 1600mg:
- •Previously untreated or relapsed/refractory CLL participants in combination with chemotherapy
排除标准
- •Pregnant or breastfeeding women
- •Participants who are out of locally approved indications, dosage, and administration including medication error
- •Contraindication in use by locally approved indications, dosage, and administration
研究组 & 干预措施
MabThera
Participants with NHL will be administered 1400 milligrams (mg) and those with with CLL will be administered 1600 mg MabThera subcutaneously at the discretion of the physician in accordance with local clinical practice and local labeling, and will be observed for 6 years.
干预措施: MabThera (Drug)
结局指标
主要结局
Percentage of Participants with Adverse Events
时间窗: Baseline up to Year 6
次要结局
- Percentage of Participants with Overall Response as Assessed by the Investigator Using the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 Criteria(Baseline up to Year 6)
- Percentage of Participants with Overall Response as Assessed by the Investigator Using the Cheson 2014 Criteria for NHL(Baseline up to Year 6)
研究者
研究点 (25)
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