Open, Noninterventional, Multicentre Trial of Rituximab in Combination With Chemotherapy (CVP, CHOP or FCM) Chemotherapy in Patients With Follicular Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 主要终点
- Number of Participants With an Adverse Event (AE), Serious AE, or Death Related to AE
研究概览
简要总结
The primary objective is to evaluate the safety profile and tolerability of rituximab in combination with different chemotherapy regimens.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •New diagnosed Stage III/IV NHLs
- •Grades 1, 2 follicular lymphoma need to be treated
- •mCD20 positive
- •Have an expected survival of 3 months or more
- •ECOG 0-2 grade
- •Normal renal function
- •ALT less than double normal level
排除标准
- •Presence of CNS lymphoma
- •Severe infectious disease or organic disease
- •Having another malignant tumor
- •Pregnant or breast-feeding female
- •Organic heart disease, heart failure, II or higher grade AV bundle block.
- •Subject is allergic to Rituximab
- •Known HIV infection or chronic HBV infection
研究组 & 干预措施
Combination Therapy
Rituximab 375mg/m2, on day 1 of each cycle of chemotherapy, total of 8 infusions. Chemotherapy according to standard regimens.
干预措施: Chemotherapy (Radiation)
Combination Therapy
Rituximab 375mg/m2, on day 1 of each cycle of chemotherapy, total of 8 infusions. Chemotherapy according to standard regimens.
干预措施: Rituximab (Drug)
结局指标
主要结局
Number of Participants With an Adverse Event (AE), Serious AE, or Death Related to AE
时间窗: Up to 3 years (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)
The safety and tolerability of rituximab was evaluated by collection of AEs, including clinically significant abnormalities and changes in laboratory data. An AE was defined as any untoward medical occurrence in a study participant regardless of the suspected cause. Serious AEs were those which, at any dose, met one or more of the following criteria: resulted in fatality, were life-threatening, necessitated new or prolonged existing hospitalization, produced persistent or significant disability, resulted in a congenital anomaly or birth defect, were considered medically significant, or required intervention to prevent any of the aforementioned outcomes. Those specific serious AEs which resulted in fatality were also reported separately.
次要结局
- Percentage of Participants Alive at 1, 2, and 3 Years(At 1, 2, and 3 years)
- Percentage of Participants With Complete Remission (CR) or Partial Remission (PR) According to International Working Group Response Criteria for Non-Hodgkin's Lymphoma (NHL)(Up to 18 months (at Screening, Baseline, end of induction therapy, and in accordance with routine practice))
- Percentage of Participants With CR According to International Working Group Response Criteria for NHL(Up to 18 months (at Screening, Baseline, end of induction therapy, and in accordance with routine practice))