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Not yet recruitingNCT06251648Updated Feb 9, 2024

Acute Lymphoblastic Leukaemia Related to Lenalidomide (LenALL)

An observational study in Cancer, sponsored by University Hospital, Caen. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-09.

Sponsored by University Hospital, Caen · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2024, 2 years 7 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
300
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

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In context

Precursor Cell Lymphoblastic Leukemia-Lymphoma

2,061 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 490 are open to participants now.

This study's planned enrollment of 300 is above the median of 120 across 300 observational studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.

Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →

Lead sponsor

University Hospital, Caen is the lead sponsor of 505 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Cancer patients treated with LEN and experiencing ALL

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

Exclusion Criteria:

-Chronology not compatible between LEN and ALL

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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
300 participants (estimated)
Patient registry
No

Interventions

  • DrugLenalidomide

    Patients exposed to LEN

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What researchers measure

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.

    Time frame: From inception to February, 2024

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Study locations

1 site
  • CHU de Caen
    Caen, 14033, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06251648
Lead sponsor
University Hospital, Caen
Responsible party
Pierre-Marie MORICE, PharmD, PhD (Dr, University Hospital, Caen) — Principal investigator
First posted
Feb 9, 2024
Start date
Feb 1, 2024 (estimated)
Primary completion
Feb 15, 2024 (estimated)
Completion
Mar 31, 2024 (estimated)
Last update
Feb 9, 2024

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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