Calquence CLL 1L Japan PMS _ Japan Post-Marketing Surveillance (PMS) Study

To understand the incidence of ADRs of Calquence capsules 100 mg (acalabrutinib) used in patients with previously untreated chronic lymphocytic leukaemia (CLL) (including small lymphocytic lymphoma (SLL)) in the post-marketing setting under actual use

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Key information

Conditions

Previously Untreated Chronic Lymphocytic Leukaemia (Including Small Lymphocytic Lymphoma)

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Aichi, Japan

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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.

Exclusion criteria

None

Treatment and study plan

Primary outcomes

Incidence of ADRs

Time frame: 24 weeks

the incidence of ADRs related to Calquence Safety Specifications : infection, bone marrow depression

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

General Use-Results Study of Calquence Capsules 100 mg in Patients With Previously Untreated Chronic Lymphocytic Leukaemia (Including Small Lymphocytic Lymphoma)

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Dec 27, 2022
Registry last updated: May 15, 2026

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.