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Trial Title:
Acute Lymphoblastic Leukaemia Related to Lenalidomide (LenALL)
NCT ID:
NCT06251648
Condition:
Cancer
Conditions: Official terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Lenalidomide
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Drug
Intervention name:
Lenalidomide
Description:
Patients exposed to LEN
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.
Criteria for eligibility:
Study pop:
Cancer patients treated with LEN and experiencing ALL
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU de Caen
Address:
City:
Caen
Zip:
14033
Country:
France
Start date:
February 1, 2024
Completion date:
March 31, 2024
Lead sponsor:
Agency:
University Hospital, Caen
Agency class:
Other
Source:
University Hospital, Caen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06251648
