Acute Lymphoblastic Leukaemia Related to Lenalidomide (LenALL)

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06251648

Enrollment

300

Registered

2024-02-09

Start date

2024-02-01

Completion date

2024-03-31

Last updated

2024-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

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.

Interventions

DRUGLenalidomide

Patients exposed to LEN

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026