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

August 27, 2019 updated by: University Hospital, Caen

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

1000000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Normandie
      • Caen, Normandie, France, 14033
        • Recruiting
        • Caen University Hospital, Department of Pharmacology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Clozapine treatment
Other Names:
  • Clozapine treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between clozapine and haematologic malignancies using a disproportionality analysis in Individual Case Reports involving at least one liable antipsychotic drug in Vigibase®.
Time Frame: Case reported in the World Health Organization (WHO) of individual safety case reports to March 2019 ]
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
investigate a potential dose-dependent effect
Time Frame: Case reported in the World Health Organization (WHO) of individual safety case reports to March 2019 ]
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 ]
Description of the clinical features of clozapine-related haematologic malignancies
Time Frame: Case reported in the World Health Organization (WHO) of individual safety case reports to March 2019 ]
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 ]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Investigators

  • Principal Investigator: Basile Chrétien, PharmD, MSc, University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

August 1, 2024

Study Registration Dates

First Submitted

August 19, 2019

First Submitted That Met QC Criteria

August 27, 2019

First Posted (Actual)

August 30, 2019

Study Record Updates

Last Update Posted (Actual)

August 30, 2019

Last Update Submitted That Met QC Criteria

August 27, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-916

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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