Clozapine and Haematologic Malignancies: Observational and Retrospective Study Using the WHO Pharmacovigilance Database

NCT04074213 | Unknown FDA Drug

• 1 other identifier: 19-916
• Study Type: observational
• Target: 1,000,000
• Locations: 1 country
• Sites: 1

Brief Summary

Clozapine may lead to various adverse reactions, including neutropenia and agranulocytosis. This study investigates reports of lymphoma and leukaemias for clozapine in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).

Conditions

Lymphoma; Leukemia

Outcome Measures

Primary Outcomes (1)

• Correlation between clozapine and haematologic malignancies using a disproportionality analysis in Individual Case Reports involving at least one liable antipsychotic drug in Vigibase®.

  Study the correlation between clozapine and haematologic malignancies by comparing the proportion of Individual Case Reports (ICSRs) of hematologic malignancies with liable clozapine with the proportion of ICSRs of hematologic malignancies with at least one liable antipsychotic.

  Case reported in the World Health Organization (WHO) of individual safety case reports to March 2019 ]

Secondary Outcomes (2)

• investigate a potential dose-dependent effect

  Case reported in the World Health Organization (WHO) of individual safety case reports to March 2019 ]

• Description of the clinical features of clozapine-related haematologic malignancies

  Case reported in the World Health Organization (WHO) of individual safety case reports to March 2019 ]

Study Arms (1)

Haematologic malignancies with clozapine

Cases reported in the World Health Organization (WHO) database of patients treated by Clozapine, with a chronology compatible with the drug toxicity

Drug: Clozapine

Interventions

Clozapine DRUG

Clozapine treatment

Also known as: Clozapine treatment

Haematologic malignancies with clozapine

Eligibility Criteria

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

Study Population

Patients treated with at least one liable antipsychotic drug (ATC class N05A)

You may qualify if:

• Case reported in the World Health Organization (WHO) database of individual safety case reports to 03/05/2019
• Adverse events reported were including the MedDRA terms: Malignant Lymphoma (SMQ), Leukaemia (HLGT)
• Patients treated with at least one liable antipsychotic drug (ATC class N05A)

You may not qualify if:

• Chronology not compatible between the drug and the toxicity

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Caen University Hospital, Department of Pharmacology

Caen, Normandy, 14033, France

RECRUITING

MeSH Terms

Conditions

Lymphoma; Leukemia

Interventions

Clozapine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hematologic Diseases

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Basile Chrétien, PharmD, MSc

  University Hospital, Caen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Basile Chrétien, PharmD, MSc

CONTACT

+33231064672; chretien-b@chu-caen.fr

Study Design

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

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 30, 2019
• Study Start: March 1, 2019
• Primary Completion: March 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 30, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)