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

• Sponsor: University Hospital, Caen (Other)
• Overall Status: Completed
• CT.gov ID: NCT04326023
• Collaborator: (none)
• Enrollment: 178
• Location: 1
• Actual Duration (Months): 2.8
• Patients Per Site Per Month: 64.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Drug: PARP Inhibitors

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 Design

• Study Type: Observational
• Actual Enrollment: 178 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• 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)
• Actual Study Start Date: Feb 9, 2020
• Actual Primary Completion Date: Mar 18, 2020
• Actual Study Completion Date: May 3, 2020

Outcome Measures

Primary Outcome Measures

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

1. Description of the median time to onset since first PARPi exposure. [From inception to May 3, 2020]

2. Description of the fatality rate. [From inception to May 3, 2020]

3. Description of patients who experienced co-reported adverse events. [From inception to May 3, 2020]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alexandre Joachim	Caen	Basse Normandie	France	14000

Sponsors and Collaborators

• University Hospital, Caen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Caen
• ClinicalTrials.gov Identifier: NCT04326023
• Other Study ID Numbers: Pharmaco 20200317
• First Posted: Mar 30, 2020
• Last Update Posted: Mar 11, 2021
• Last Verified: May 1, 2020

• 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
• Additional relevant MeSH terms: Leukemia, Myeloid, Acute; Preleukemia; Myelodysplastic Syndromes; Poly(ADP-ribose) Polymerase Inhibitors

Study Results

No Results Posted as of Mar 11, 2021