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临床试验/NCT04618081
NCT04618081已完成不适用

Revlimid® Capsules General Drug Use-results Survey (Relapsed or Refractory Follicular Lymphoma and Marginal Zone Lymphoma)

Celgene1 个研究点 分布在 1 个国家目标入组 151 人开始时间: 2020年12月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Celgene
入组人数
151
试验地点
1
主要终点
Adverse Events (AEs)

研究概览

简要总结

To ascertain the safety of Revlimid® Capsules 2.5 mg or 5 mg under the actual use conditions in patients who received R2 combination therapy with the drug and rituximab for the first time for relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL).

In particular, this surveillance will collect only information of occurrence state and treatment methods on bone marrow depression (neutropenia), which is specified as a safety specification, as well as on tumor flare, for which attention should be called.

  1. Planned registration period 1.5 years
  2. Planned surveillance period 3 years from the start of this survey

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • Relapsed or Refractory Follicular Lymphoma or Marginal Zone Lymphoma

排除标准

  • 未提供

结局指标

主要结局

Adverse Events (AEs)

时间窗: Up to approximately 3 years

Number of participants with adverse events

次要结局

未报告次要终点

研究者

发起方
Celgene
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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