An observational study in Cancer, sponsored by University Hospital, Caen. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2021-03-11.
Sponsored by University Hospital, Caen · Observational
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 (MDS) and/or acute myeloid leukaemia (AML). Today, data about MDS/AML are scarce.
The objective was to investigate reports of MDS/AML adverse events related to PARPi, including olaparib, rucaparib, niraparib, talazoparib and veliparib using the World Health Organization (WHO) and the French pharmacovigilance databases.
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.
2,971 studies on the registry are indexed under Leukemia, Myeloid, Acute; 745 are open to participants now.
This study's enrollment of 178 is above the median of 120 across 317 observational studies indexed under Leukemia, Myeloid, Acute.
Browse Leukemia, Myeloid, Acute studies →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.
Cancer patients treated with PARPi and experiencing MDS/AML.
Exclusion Criteria:
olaparib, rucaparib, niraparib, talazoparib, veliparib
MDS/AML reports related to PARPi (from WHO database).
Identification of the MDS and/or AML adverse event related to PARP inhibitors reported in the World Health Organization (WHO) database of individual safety case reports.
Time frame: From inception to May 3, 2020
MDS/AML reports related to PARPi (from French database).
Identification of the MDS and/or AML adverse event related to PARP inhibitors reported in the French pharmacovigilance database of individual safety case reports. The aim is to describe clinical features of these rare adverse events, including bone marrow analyzes, cytogenetic and molecular abnormalities, blasts immunophenotyping anonymously reported in this database.
Time frame: From inception to May 1, 2021
Description of the median time to onset since first PARPi exposure.
Time frame: From inception to May 3, 2020
Description of the fatality rate.
Time frame: From inception to May 3, 2020
Description of patients who experienced co-reported adverse events.
Time frame: From inception to May 3, 2020
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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University Hospital, Caen