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

Cancer Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04326023
• Other study ID #: Pharmaco 20200317
• Status: Completed
• Start date: February 9, 2020
• Est. completion date: May 3, 2020

Study information

• Verified date: May 2020
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: May 3, 2020
• Est. primary completion date: March 18, 2020
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Cancer
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndromes
• Preleukemia

Intervention

Drug:
• PARP Inhibitors
olaparib, rucaparib, niraparib, talazoparib, veliparib

Locations

Country	Name	City	State
France	Alexandre Joachim	Caen	Basse Normandie

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MDS/AML reports related to PARPi (from WHO database).	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
Primary	MDS/AML reports related to PARPi (from French database).	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	Description of the median time to onset since first PARPi exposure.		From inception to May 3, 2020
Secondary	Description of the fatality rate.		From inception to May 3, 2020
Secondary	Description of patients who experienced co-reported adverse events.		From inception to May 3, 2020