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Completed

NCT Number: NCT04872621

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

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

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Key information

Conditions

Relapsed or Refractory Chronic Lymphocytic Leukemia (Including Small Lymphocytic Lymphoma) Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Aichi, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

None

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Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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)

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 4, 2021
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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