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

NCT04326023 | Completed FDA Drug

• 1 other identifier: Pharmaco 20200317
• Study Type: observational
• Target: 178
• Locations: 1 country
• Sites: 1

Brief 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

Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

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

  From inception to May 3, 2020

• Description of the fatality rate.

  From inception to May 3, 2020

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

  From inception to May 3, 2020

Interventions

PARP Inhibitors DRUG

olaparib, rucaparib, niraparib, talazoparib, veliparib

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cancer patients treated with PARPi and experiencing MDS/AML.

You may qualify if:

• 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).

You may not qualify if:

• Chronology not compatible between the PARPi and adverse event (MDS/AML)

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Alexandre Joachim

Caen, Basse Normandie, 14000, France

Location

Related Publications (1)

• Morice PM, Leary A, Dolladille C, Chretien B, Poulain L, Gonzalez-Martin A, Moore K, O'Reilly EM, Ray-Coquard I, Alexandre J. Myelodysplastic syndrome and acute myeloid leukaemia in patients treated with PARP inhibitors: a safety meta-analysis of randomised controlled trials and a retrospective study of the WHO pharmacovigilance database. Lancet Haematol. 2021 Feb;8(2):e122-e134. doi: 10.1016/S2352-3026(20)30360-4. Epub 2020 Dec 18.

  PMID: 33347814 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Poly(ADP-ribose) Polymerase Inhibitors

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents; Therapeutic Uses

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 30, 2020
• Study Start: February 9, 2020
• Primary Completion: March 18, 2020
• Study Completion: May 3, 2020
• Last Updated: March 11, 2021

Record last verified: 2020-05

Locations

FR (1)