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NCT06251648 Clinical Trial

Acute Lymphoblastic Leukaemia Related to Lenalidomide (LenALL)

Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06251648
Other study ID # LenALL#01-02-2024
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 1, 2024
Est. completion date March 31, 2024

Study information
Verified date February 2024
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 300
Est. completion date March 31, 2024
Est. primary completion date February 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Lenalidomide
Patients exposed to LEN

Locations
Country Name City State
France CHU de Caen Caen

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary ALL reports related to LEN (from WHO database). Identification of the ALL adverse events related to LEN reported in the World Health Organization (WHO) database of individual safety case reports. From inception to February, 2024
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