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

Lymphoma Clinical Trial

— CLOZARIX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04074213
• Other study ID #: 19-916
• Status: Recruiting
• Start date: March 1, 2019
• Est. completion date: August 1, 2024

Study information

• Verified date: August 2019
• Source: University Hospital, Caen
• Contact: Basile Chrétien, PharmD, MSc
• Phone: +33231064672
• Email: chretien-b[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

Clozapine is responsible of a wide range of adverse side effects.The investigators use VigiBase, the World Health Organization (WHO) database of individual safety case reports, to identify cases of haematologic malignancies following treatment with clozapine.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000000
• Est. completion date: August 1, 2024
• Est. primary completion date: March 1, 2024
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Chronology not compatible between the drug and the toxicity

Related Conditions & MeSH terms

• Leukemia
• Lymphoma
• Neoplasms

Intervention

Drug:
• Clozapine
Clozapine treatment

Locations

Country	Name	City	State
France	Caen University Hospital, Department of Pharmacology	Caen	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	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	investigate a potential dose-dependent effect	To investigate a potential dose-dependent effect, we will collect the clozapine daily dose from all clozapine ICSRs. In ICSRs with liable clozapine, the clozapine daily dose in mg will be divided into quartiles. A disproportionality analysis will be performed to evaluate the effect of the clozapine daily dose on the reporting of lymphomas and leukaemia. A significant difference of proportion of reports of haematologic malignancies between each quartile will be researched.	Case reported in the World Health Organization (WHO) of individual safety case reports to March 2019 ]
Secondary	Description of the clinical features of clozapine-related haematologic malignancies	Description of the clinical features (mean age, sex ratio, time to onset, daily dose) of clozapine-related haematologic malignancies according to the main clinical subtypes	Case reported in the World Health Organization (WHO) of individual safety case reports to March 2019 ]