NCT06251648

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2024

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

February 9, 2024

Status Verified

February 1, 2024

Enrollment Period

14 days

First QC Date

February 1, 2024

Last Update Submit

February 1, 2024

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

LenalidomideDRUG

Patients exposed to LEN

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cancer patients treated with LEN and experiencing ALL

You may qualify if:

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

You may not qualify if:

  • Chronology not compatible between LEN and ALL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Caen

Caen, 14033, France

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Lenalidomide

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 1, 2024

First Posted

February 9, 2024

Study Start

February 1, 2024

Primary Completion

February 15, 2024

Study Completion

March 31, 2024

Last Updated

February 9, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)