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Calquence CLL 1L Japan PMS _ Japan Post-Marketing Surveillance (PMS) Study

Sponsor
AstraZeneca (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05665374
Collaborator
(none)
50
Enrollment
40.7
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

To understand the incidence of ADRs of Calquence capsules 100 mg (acalabrutinib) used in patients with previously untreated chronic lymphocytic leukaemia (CLL) (including small lymphocytic lymphoma (SLL)) in the post-marketing setting under actual use.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    To understand the incidence of ADRs of Calquence capsules 100 mg (acalabrutinib) (hereinafter referred to as "CALQUENCE") used in patients with previously untreated chronic lymphocytic leukaemia (CLL) (including small lymphocytic lymphoma (SLL)) in the post-marketing setting under actual use.

    This investigation will be conducted as the additional pharmacovigilance activity specified in the Japan Risk Management Plan (J-RMP) of CALQUENCE, in compliance with the Ministerial Ordinance on Good Post-marketing Study Practice (GPSP Ordinance) and for the purpose of application for re-examination under Article 14-4 of the Law for Ensuring Quality, Efficacy, and Safety of Drugs and Medical Devices (PMD Act).

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    General Use-Results Study of Calquence Capsules 100 mg in Patients With Previously Untreated Chronic Lymphocytic Leukaemia (Including Small Lymphocytic Lymphoma)
    Anticipated Study Start Date :
    Dec 19, 2022
    Anticipated Primary Completion Date :
    May 11, 2026
    Anticipated Study Completion Date :
    May 11, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of ADRs [24 weeks]

      the incidence of ADRs related to Calquence Safety Specifications : infection, bone marrow depression

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Patients with previously untreated chronic lymphocytic leukaemia (including small lymphocytic lymphoma) who are treated with Calquence for the first time will be enrolled in the study after the approval date of the sJNDA for the additional indication.

    -

    Exclusion Criteria:

    None

    -

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    • Study Director: Toshimitsu Tokimoto, AstraZeneca KK

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT05665374
    Other Study ID Numbers:
    • D822EC00001
    First Posted:
    Dec 27, 2022
    Last Update Posted:
    Dec 27, 2022
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Additional relevant MeSH terms:
    Lymphoma
    Leukemia
    Leukemia, Lymphoid
    Leukemia, Lymphocytic, Chronic, B-Cell

    Study Results

    No Results Posted as of Dec 27, 2022