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Calquence CLL rr Japan PMS_Japan Post-Marketing Surveillance (PMS) Study - All Patient Investigation

Sponsor
AstraZeneca (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04872621
Collaborator
(none)
18
Enrollment
40
Locations
39
Anticipated Duration (Months)
0.5
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To understand the incidence of ADRs of Calquence 100 mg capsules (acalabrutinib) used in patients with relapsed or refractory chronic lymphocytic leukaemia (including small lymphocytic lymphoma) in a real-world post-marketing setting

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    To understand the incidence of ADRs of Calquence 100 mg capsules (acalabrutinib) used in patients with relapsed or refractory chronic lymphocytic leukaemia (including small lymphocytic lymphoma) in a real-world post-marketing setting.

    This investigation will be conducted for application for re-examination specified in Article 14-4 of the Pharmaceutical Affairs Law. In addition, after launch, the data for a certain number of all cases are collected and the survey is required to be conducted for all cases as conditions of approval.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    18 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Calquence 100 mg Capsules General Drug Use-Results Study; All Patient Investigation in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (Including Small Lymphocytic Lymphoma)
    Actual Study Start Date :
    Jun 30, 2021
    Anticipated Primary Completion Date :
    Sep 30, 2024
    Anticipated Study Completion Date :
    Sep 30, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of ADRs [52weeks]

      the incidence of ADRs related to Calquence Safety specifications: Haemorrhage, infection, bone narrow depression, arrhythmia, ischemic heart disease, tumour lysis syndrome, interstitial lung disease, and second primary malignancy

    Eligibility Criteria

    Criteria

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

    Patients with relapsed or refractory chronic lymphocytic leukemia (small lymphocytic lymphoma) who are treated with the product -

    Exclusion Criteria:

    None

    -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Aichi Japan D8224C00001
    2 Research Site Aichi Japan
    3 Research Site Akita Japan
    4 Research Site Aomori Japan D8224C00001
    5 Research Site Chiba Japan D8224C00001
    6 Research Site Chiba Japan
    7 Research Site Fukui Japan
    8 Research Site Fukuoka Japan D8224C00001
    9 Research Site Fukuoka Japan
    10 Research Site Gunma Japan D8224C00001
    11 Research Site Gunma Japan
    12 Research Site Hiroshima Japan
    13 Research Site Hokkaido Japan D8224C00001
    14 Research Site Hokkaido Japan
    15 Research Site Hyogo Japan
    16 Research Site Ibaraki Japan D8224C00001
    17 Research Site Ibaraki Japan
    18 Research Site Ishikawa Japan
    19 Research Site Kagoshima Japan D8224C00001
    20 Research Site Kagoshima Japan
    21 Research Site Kanagawa Japan D8224C00001
    22 Research Site Kanagawa Japan
    23 Research Site Kyoto Japan D8224C00001
    24 Research Site Miyagi Japan
    25 Research Site Miyazaki Japan
    26 Research Site Nagasaki Japan D8224C00001
    27 Research Site Nara Japan
    28 Research Site Niigata Japan
    29 Research Site Osaka Japan D8224C00001
    30 Research Site Osaka Japan
    31 Research Site Saitama Japan
    32 Research Site Shiga Japan D8224C00001
    33 Research Site Shiga Japan
    34 Research Site Shizuoka Japan D8224C00001
    35 Research Site Shizuoka Japan
    36 Research Site Tokyo Japan D8224C00001
    37 Research Site Tokyo Japan
    38 Research Site Toyama Japan
    39 Research Site Wakayama Japan D8224C00001
    40 Research Site Wakayama Japan

    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:
    NCT04872621
    Other Study ID Numbers:
    • D8224C00001
    First Posted:
    May 4, 2021
    Last Update Posted:
    Jun 10, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Lymphoma
    Leukemia
    Leukemia, Lymphoid
    Leukemia, Lymphocytic, Chronic, B-Cell

    Study Results

    No Results Posted as of Jun 10, 2022