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

C

Caen University Hospital

Status

Completed

Conditions

Cancer

Treatments

Drug: PARP Inhibitors

Study type

Observational

Funder types

Other

Identifiers

NCT04326023
Pharmaco 20200317

Details and patient eligibility

About

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.

Full 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.

Enrollment

178 patients

Sex

All

Volunteers

No Healthy Volunteers

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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