Calquence CLL 1L Japan PMS _ Japan Post-Marketing Surveillance (PMS) Study
- Conditions
- Previously Untreated Chronic Lymphocytic Leukaemia (Including Small Lymphocytic Lymphoma)
- Registration Number
- NCT05665374
- Lead Sponsor
- AstraZeneca
- Brief Summary
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
- 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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 67
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.
None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of ADRs 24 weeks the incidence of ADRs related to Calquence Safety Specifications : infection, bone marrow depression
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Research Site
🇯🇵Yamanashi, Japan