临床试验/NCT06251648

NCT06251648尚未招募不适用

Acute Lymphoblastic Leukaemia Related to Lenalidomide in Patients With Cancer: an Observational and Retrospective Study Using the WHO's Pharmacovigilance Database

University Hospital, Caen1 个研究点分布在 1 个国家目标入组 300 人开始时间: 2024年2月1日最近更新: 2024年2月9日

适应症

试验速览

阶段: 不适用
状态: 尚未招募
发起方: University Hospital, Caen
入组人数: 300
试验地点: 1
主要终点: ALL reports related to LEN (from WHO database).

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Although lenalidomide (LEN) have proved effective in treating many cancers, few patients receiving LEN may experience rare but life-threatening adverse events such as Acute Lymphoblastic Leukaemia (ALL). Today, data about ALL are scarce.

The objective was to investigate reports of ALL adverse events related to LEN in patients with cancer using the World Health Organization (WHO) pharmacovigilance database.

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: 否

入选标准

•Case reported in the World Health Organization (WHO, also called VigiBase) at the time of the extraction
•Patients treated with at least LEN (L04AX04)

排除标准

•Chronology not compatible between LEN and ALL

结局指标

主要结局

ALL reports related to LEN (from WHO database).

时间窗: From inception to February, 2024

Identification of the ALL adverse events related to LEN reported in the World Health Organization (WHO) database of individual safety case reports.

次要结局

未报告次要终点

研究者

发起方

University Hospital, Caen

申办方类型

Other

责任方

Principal Investigator

主要研究者

Pierre-Marie MORICE, PharmD, PhD

University Hospital, Caen

研究点 (1)

Loading locations...

相似试验

已完成

2 期

A Phase II Clinical Trial of Lenalidomide for T-cell Non-Hodgkin's LymphomaT-cell Lymphoma

NCT00322985AHS Cancer Control Alberta40

终止

1 期

Phase I Study of Lenalidomide in Patients With Acute LeukemiaAcute Leukemia

NCT01615042Mehrdad Abedi, MD6

Unknown

2 期

Trial of Lenalidomide in Patients With Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) TypeMALT Lymphoma

NCT00923663Medical University of Vienna16

撤回

2 期

Lenalidomide in Treating Patients With High-Risk Chronic Lymphocytic LeukemiaStage III Chronic Lymphocytic LeukemiaStage IV Chronic Lymphocytic LeukemiaChronic Lymphocytic Leukemia

NCT01271283National Cancer Institute (NCI)

已完成

2 期

Lenalidomide Following Fludarabine/Rituximab (FR) in Untreated Chronic Lymphocytic Leukemia (CLL)Chronic Lymphocytic Leukemia

NCT00860457Georgetown University22