Trial Title:
Calquence CLL 1L Japan PMS _ Japan Post-Marketing Surveillance (PMS) Study
NCT ID:
NCT05665374
Condition:
Previously Untreated Chronic Lymphocytic Leukaemia (Including Small Lymphocytic Lymphoma)
Conditions: Official terms:
Lymphoma
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
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).
Criteria for eligibility:
Study pop:
Patients with previously untreated chronic lymphocytic leukaemia (including small
lymphocytic lymphoma) who are treated with Calquence
Sampling method:
Non-Probability Sample
Criteria:
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
-
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Aichi
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Chiba
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Fukuoka
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Hyogo
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Ibaraki
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Kanagawa
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Kyoto
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Miyazaki
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Nagano
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Nara
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Oita
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Okayama
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Osaka
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Saitama
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Shizuoka
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Tokyo
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Yamaguchi
Country:
Japan
Facility:
Name:
Research Site
Address:
City:
Yamanashi
Country:
Japan
Start date:
June 19, 2023
Completion date:
May 11, 2026
Lead sponsor:
Agency:
AstraZeneca
Agency class:
Industry
Source:
AstraZeneca
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05665374
