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)
Sponsor study identifier
observational
104
1 country
59
Study Start
June 30, 2021
Actual (reported)Primary Completion
September 4, 2024
Actual (reported)Study Completion
September 4, 2024
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 4, 2024
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 30, 2021
Actual (reported)May 4, 2021
Actual (reported)June 30, 2021
Actual (reported)September 4, 2024
Actual (reported)September 4, 2024
Actual (reported)Incidence of ADRs
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
Patients with relapsed or refractory chronic lymphocytic leukaemia (small lymphocytic lymphoma) who are treated with the product
Research Site
Aichi, D8224C00001, Japan
Research Site
Aichi, Japan
Research Site
Akita, Japan
Research Site
Aomori, D8224C00001, Japan
Research Site
Chiba, D8224C00001, Japan
Research Site
Chiba, Japan
Research Site
Fukui, Japan
Research Site
Toshimitsu Tokimoto
AstraZeneca KK
104 participants (actual enrollment reported by the registry).
First Submitted
April 30, 2021
First Posted
May 4, 2021
Study Start
June 30, 2021
Actual (reported)Contact the study team to confirm eligibility.
Fukuoka, D8224C00001, Japan
Research Site
Fukuoka, Japan
Research Site
Gifu, Japan
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Gunma, D8224C00001, Japan
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Gunma, Japan
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Hiroshima, D8224C00001, Japan
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Hiroshima, Japan
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Hokkaido, D8224C00001, Japan
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Hokkaido, Japan
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Hyōgo, D8224C00001, Japan
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Hyōgo, Japan
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Ibaraki, D8224C00001, Japan
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Ibaraki, Japan
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Ishikawa, Japan
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Kagoshima, D8224C00001, Japan
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Kagoshima, Japan
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Kanagawa, D8224C00001, Japan
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Kanagawa, Japan
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Kochi, Japan
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Kumamoto, Japan
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Kyoto, D8224C00001, Japan
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Kyoto, Japan
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Mie, Japan
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Miyagi, D8224C00001, Japan
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Miyagi, Japan
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Miyazaki, Japan
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Nagano, Japan
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Nagasaki, D8224C00001, Japan
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Nagasaki, Japan
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Nara, Japan
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Niigata, Japan
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Numakunai, Japan
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Okayama, Japan
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Okinawa, Japan
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Osaka, D8224C00001, Japan
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Osaka, Japan
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Ōita, Japan
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Saitama, D8224C00001, Japan
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Saitama, Japan
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Shiga, D8224C00001, Japan
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Shiga, Japan
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Shimane, Japan
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Shizuoka, D8224C00001, Japan
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Shizuoka, Japan
Research Site
Tokyo, D8224C00001, Japan
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Tokyo, Japan
Research Site
Tottori, Japan
Research Site
Toyama, Japan
Research Site
Wakayama, D8224C00001, Japan
Research Site
Wakayama, Japan
Research Site
Yamagata, Japan
Research Site
Yamaguchi, Japan
Primary Completion
September 4, 2024
Actual (reported)Study Completion
September 4, 2024
Actual (reported)Last Updated
September 2, 2025
Record last verified: 2025-08
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.
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Source: ClinicalTrials.gov.
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