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

August 26, 2025 updated by: AstraZeneca

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)

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

104

Contacts and Locations

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

Study Locations

  • Japan
      • Aichi, Japan
        • Research Site
      • Aichi, Japan, D8224C00001
        • Research Site
      • Akita, Japan
        • Research Site
      • Aomori, Japan, D8224C00001
        • Research Site
      • Chiba, Japan
        • Research Site
      • Chiba, Japan, D8224C00001
        • Research Site
      • Fukui, Japan
        • Research Site
      • Fukuoka, Japan
        • Research Site
      • Fukuoka, Japan, D8224C00001
        • Research Site
      • Gifu, Japan
        • Research Site
      • Gunma, Japan
        • Research Site
      • Gunma, Japan, D8224C00001
        • Research Site
      • Hiroshima, Japan
        • Research Site
      • Hiroshima, Japan, D8224C00001
        • Research Site
      • Hokkaido, Japan
        • Research Site
      • Hokkaido, Japan, D8224C00001
        • Research Site
      • Hyōgo, Japan
        • Research Site
      • Hyōgo, Japan, D8224C00001
        • Research Site
      • Ibaraki, Japan
        • Research Site
      • Ibaraki, Japan, D8224C00001
        • Research Site
      • Ishikawa, Japan
        • Research Site
      • Kagoshima, Japan
        • Research Site
      • Kagoshima, Japan, D8224C00001
        • Research Site
      • Kanagawa, Japan
        • Research Site
      • Kanagawa, Japan, D8224C00001
        • Research Site
      • Kochi, Japan
        • Research Site
      • Kumamoto, Japan
        • Research Site
      • Kyoto, Japan
        • Research Site
      • Kyoto, Japan, D8224C00001
        • Research Site
      • Mie, Japan
        • Research Site
      • Miyagi, Japan
        • Research Site
      • Miyagi, Japan, D8224C00001
        • Research Site
      • Miyazaki, Japan
        • Research Site
      • Nagano, Japan
        • Research Site
      • Nagasaki, Japan
        • Research Site
      • Nagasaki, Japan, D8224C00001
        • Research Site
      • Nara, Japan
        • Research Site
      • Niigata, Japan
        • Research Site
      • Numakunai, Japan
        • Research Site
      • Okayama, Japan
        • Research Site
      • Okinawa, Japan
        • Research Site
      • Osaka, Japan
        • Research Site
      • Osaka, Japan, D8224C00001
        • Research Site
      • Saitama, Japan
        • Research Site
      • Saitama, Japan, D8224C00001
        • Research Site
      • Shiga, Japan
        • Research Site
      • Shiga, Japan, D8224C00001
        • Research Site
      • Shimane, Japan
        • Research Site
      • Shizuoka, Japan
        • Research Site
      • Shizuoka, Japan, D8224C00001
        • Research Site
      • Tokyo, Japan
        • Research Site
      • Tokyo, Japan, D8224C00001
        • Research Site
      • Tottori, Japan
        • Research Site
      • Toyama, Japan
        • Research Site
      • Wakayama, Japan
        • Research Site
      • Wakayama, Japan, D8224C00001
        • Research Site
      • Yamagata, Japan
        • Research Site
      • Yamaguchi, Japan
        • Research Site
      • Ōita, Japan
        • Research Site

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

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

None

-

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: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of ADRs
Time Frame: 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
52weeks

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Study Director: Toshimitsu Tokimoto, AstraZeneca KK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

June 30, 2021

Primary Completion (Actual)

September 4, 2024

Study Completion (Actual)

September 4, 2024

Study Registration Dates

First Submitted

April 30, 2021

First Submitted That Met QC Criteria

April 30, 2021

First Posted (Actual)

May 4, 2021

Study Record Updates

Last Update Posted (Estimated)

September 2, 2025

Last Update Submitted That Met QC Criteria

August 26, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D8224C00001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluatedas per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes,indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level datain an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access.For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

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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