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临床试验/NCT03098589
NCT03098589已完成不适用

Revlimid® Capsules Drug Use-results Surveillance Relapsed or Refractory Adult T-cell Leukemia Lymphoma

Celgene1 个研究点 分布在 1 个国家目标入组 1,149 人开始时间: 2017年5月30日最近更新:
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
发起方
Celgene
入组人数
1,149
试验地点
1
主要终点
Adverse Events (AEs)

研究概览

简要总结

To understand the safety and efficacy of Revlimid® Capsules 2.5 mg and 5 mg (hereinafter referred to as Revlimid) under actual conditions of use in patients with relapsed or refractory adult T-cell leukemia lymphoma (hereinafter referred to as relapsed or refractory Adult T-cell Leukemia Lymphoma (ATLL)).

  1. Planned registration period 3 years
  2. Planned surveillance period 4 years and 6 months after a month after the approval for partial changes in the approved items is granted for relapsed or refractory ATLL

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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 Adult T-cell Leukemia Lymphoma

排除标准

  • 未提供

研究组 & 干预措施

Patients with T-cell leukemia lymphoma treated with Revlimid

Among patients with relapsed or refractory adult T-cell leukemia lymphoma, patients who received Revlimid will be targeted in this surveillance

干预措施: Revlimid (Drug)

结局指标

主要结局

Adverse Events (AEs)

时间窗: Up to approximately 4 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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