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

NCT04326023 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 178

Last updated 2021-03-11

No results posted yet for this study

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.

Conditions

Interventions

DRUG

PARP Inhibitors

olaparib, rucaparib, niraparib, talazoparib, veliparib

Sponsors & Collaborators

  • University Hospital, Caen

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-09
Primary Completion
2020-03-18
Completion
2020-05-03
FDA Drug
Yes

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04326023 on ClinicalTrials.gov