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

AstraZeneca

Status: Active, not recruiting

Conditions: Previously Untreated Chronic Lymphocytic Leukaemia (Including Small Lymphocytic Lymphoma)

Study type: Observational

Funder types: Industry

Identifiers

NCT05665374

D822EC00001

Details and patient eligibility

About

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

Full 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).

Enrollment: 67 patients

Sex: All

Volunteers: No Healthy Volunteers

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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