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

March 9, 2021 updated by: University Hospital, Caen

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

178

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Basse Normandie
      • Caen, Basse Normandie, France, 14000
        • Alexandre Joachim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cancer patients treated with PARPi and experiencing MDS/AML.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From inception to May 3, 2020
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.
From inception to May 1, 2021

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2020

Primary Completion (Actual)

March 18, 2020

Study Completion (Actual)

May 3, 2020

Study Registration Dates

First Submitted

March 26, 2020

First Submitted That Met QC Criteria

March 26, 2020

First Posted (Actual)

March 30, 2020

Study Record Updates

Last Update Posted (Actual)

March 11, 2021

Last Update Submitted That Met QC Criteria

March 9, 2021

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pharmaco 20200317

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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