Acute Lymphoblastic Leukaemia Related to Lenalidomide (LenALL)

Not yet recruiting

• Conditions: Cancer

• Registration Number: NCT06251648
• Lead Sponsor: University Hospital, Caen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-02
• Study Start: 2024-02-01
• Study First Submitted: 2024-02-01
• Study First Submitted QC: 2024-02-01
• Last Update Submitted: 2024-02-01
• Study First Posted: 2024-02-09
• Last Update Posted: 2024-02-09
• Primary Completion: 2024-02-15
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

-Chronology not compatible between LEN and ALL

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ALL reports related to LEN (from WHO database).	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.

Trial Locations

Locations (1)

CHU de Caen; 🇫🇷 Caen, France