NCT04326023

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

Myelodysplastic Syndrome and Acute Myeloid Leukemia Related to PARP Inhibitors in Cancer Patients : an Observational and Retrospective Study Using the WHO and the French Pharmacovigilance Databases (MyeloRIB)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 178 (actual)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: —

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.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	PARP Inhibitors	olaparib, rucaparib, niraparib, talazoparib, veliparib

Timeline

• Start date: 2020-02-09
• Primary completion: 2020-03-18
• Completion: 2020-05-03
• First posted: 2020-03-30
• Last updated: 2021-03-11

Locations

1 site across 1 country: France

Regulatory

• FDA-regulated drug study