Myelodysplastic Syndrome and Acute Myeloid Leukemia Related to PARP Inhibitors (MyeloRIB)

Completed

• Conditions: Cancer

• Registration Number: NCT04326023
• Lead Sponsor: University Hospital, Caen

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 (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.

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.

Study Timeline

• Study Start: 2020-02-09
• Primary Completion: 2020-03-18
• Study First Submitted: 2020-03-26
• Study First Submitted QC: 2020-03-26
• Study First Posted: 2020-03-30
• Status Verified: 2020-05
• Study Completion: 2020-05-03
• Last Update Submitted: 2021-03-09
• Last Update Posted: 2021-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

Inclusion Criteria

• 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 Criteria

• Chronology not compatible between the PARPi and adverse event (MDS/AML)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MDS/AML reports related to PARPi (from French database).	From inception to May 1, 2021	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.
MDS/AML reports related to PARPi (from WHO database).	From inception to May 3, 2020	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.

Secondary Outcome Measures

Name	Time	Method
Description of the fatality rate.	From inception to May 3, 2020
Description of the median time to onset since first PARPi exposure.	From inception to May 3, 2020
Description of patients who experienced co-reported adverse events.	From inception to May 3, 2020

Trial Locations

Locations (1)

Alexandre Joachim; 🇫🇷 Caen, Basse Normandie, France