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Completed

NCT Number: NCT04326023

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

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.

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Key information

Conditions

Cancer Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Alexandre Joachim

Caen, Basse Normandie, 14000, France

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

PARP Inhibitors

Drug

olaparib, rucaparib, niraparib, talazoparib, veliparib

Primary outcomes

  1. MDS/AML reports related to PARPi (from WHO database).

    Time frame: 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.

  2. MDS/AML reports related to PARPi (from French database).

    Time frame: 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.

Secondary outcomes

  1. Description of the median time to onset since first PARPi exposure.

    Time frame: From inception to May 3, 2020

  2. Description of the fatality rate.

    Time frame: From inception to May 3, 2020

  3. Description of patients who experienced co-reported adverse events.

    Time frame: From inception to May 3, 2020

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

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)

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 30, 2020
Registry last updated
Mar 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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