Status:
COMPLETED
Myelodysplastic Syndrome and Acute Myeloid Leukemia Related to PARP Inhibitors (MyeloRIB)
Lead Sponsor:
University Hospital, Caen
Conditions:
Cancer
Eligibility:
All Genders
Brief Summary
Although PARP inhibitors (PARPi) have proved effective in treating many cancers, few patients receiving PARPi may experience rare but life-threatening adverse events such as myelodysplastic syndrome (...
Detailed Description
Here, investigators use the World Health Organization (WHO) and the French database of individual safety case reports, to identify cases of MDS/AML related to PARPi.
Eligibility Criteria
Inclusion
- Case reported in the World Health Organization (WHO, also called VigiBase) or French database of individual safety case reports at the time of the extraction,
- Patients treated with at least 1 PARPi (with ATC classification system): olaparib (ATC L01XX46), niraparib (ATC L01XX54), rucaparib (ATC L01XX55), talazoparib (ATC L01XX60), veliparib (none).
Exclusion
- Chronology not compatible between the PARPi and adverse event (MDS/AML)
Key Trial Info
Start Date :
February 9 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 3 2020
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT04326023
Start Date
February 9 2020
End Date
May 3 2020
Last Update
March 11 2021
Active Locations (1)
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1
Alexandre Joachim
Caen, Basse Normandie, France, 14000