- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05665374
Calquence CLL 1L Japan PMS _ Japan Post-Marketing Surveillance (PMS) Study
General Use-Results Study of Calquence Capsules 100 mg in Patients With Previously Untreated Chronic Lymphocytic Leukaemia (Including Small Lymphocytic Lymphoma)
Study Overview
Status
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: AstraZeneca Clinical Study Information Center
- Phone Number: 1-877-240-9479
- Email: information.center@astrazeneca.com
Study Locations
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Aichi, Japan
- Recruiting
- Research Site
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Chiba, Japan
- Recruiting
- Research Site
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Fukuoka, Japan
- Recruiting
- Research Site
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Fukuoka, Japan
- Not yet recruiting
- Research Site
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Hyogo, Japan
- Active, not recruiting
- Research Site
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Hyogo, Japan
- Recruiting
- Research Site
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Ibaraki, Japan
- Active, not recruiting
- Research Site
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Kanagawa, Japan
- Recruiting
- Research Site
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Kyoto, Japan
- Recruiting
- Research Site
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Kyoto, Japan
- Withdrawn
- Research Site
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Miyazaki, Japan
- Recruiting
- Research Site
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Nagano, Japan
- Recruiting
- Research Site
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Nara, Japan
- Recruiting
- Research Site
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Nara, Japan
- Active, not recruiting
- Research Site
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Oita, Japan
- Active, not recruiting
- Research Site
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Okayama, Japan
- Recruiting
- Research Site
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Osaka, Japan
- Active, not recruiting
- Research Site
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Osaka, Japan
- Recruiting
- Research Site
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Osaka, Japan
- Not yet recruiting
- Research Site
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Osaka, Japan
- Withdrawn
- Research Site
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Saitama, Japan
- Recruiting
- Research Site
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Shizuoka, Japan
- Not yet recruiting
- Research Site
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Tokyo, Japan
- Recruiting
- Research Site
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Tokyo, Japan
- Not yet recruiting
- Research Site
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Yamaguchi, Japan
- Active, not recruiting
- Research Site
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Yamanashi, Japan
- Not yet recruiting
- Research Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
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Exclusion Criteria:
None
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Study Plan
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: 24 weeks
|
the incidence of ADRs related to Calquence Safety Specifications : infection, bone marrow depression
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24 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Toshimitsu Tokimoto, AstraZeneca KK
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Disease Attributes
- Hematologic Diseases
- Leukemia, B-Cell
- Chronic Disease
- Lymphoma
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
Other Study ID Numbers
- D822EC00001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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 evaluated as 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
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
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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