Calquence CLL 1L Japan PMS _ Japan Post-Marketing Surveillance (PMS) Study
Launched by ASTRAZENECA · Dec 16, 2022
Trial Information
Current as of May 21, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial, called the Calquence CLL 1L Japan Post-Marketing Surveillance Study, is looking at the safety of a medication called Calquence (also known as acalabrutinib) in patients who have just been diagnosed with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). The goal is to see if there are any side effects when Calquence is used in real life by patients who are starting treatment for the first time.
To participate in this study, you need to be an adult with previously untreated CLL or SLL and will be starting treatment with Calquence. There are no specific exclusions based on other health conditions. While the study is currently active, it is not recruiting new participants at this time. If you join, you can expect regular check-ins to monitor your health and any possible side effects from the medication. This research is important because it helps us understand how Calquence works outside of a clinical trial setting and ensures it is safe for patients like you.
Gender
ALL
Eligibility 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
- • -
About Astrazeneca
AstraZeneca is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines across various therapeutic areas, including oncology, cardiovascular, respiratory, and autoimmune diseases. With a strong commitment to scientific research and patient-centric solutions, AstraZeneca leverages cutting-edge technology and a robust pipeline to address unmet medical needs. The company collaborates with healthcare professionals, academic institutions, and other organizations to advance clinical trials and deliver transformative therapies, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chiba, , Japan
Fukuoka, , Japan
Oita, , Japan
Osaka, , Japan
Saitama, , Japan
Tokyo, , Japan
Okayama, , Japan
Kyoto, , Japan
Miyazaki, , Japan
Shizuoka, , Japan
Yamaguchi, , Japan
Hyogo, , Japan
Ibaraki, , Japan
Kanagawa, , Japan
Nagano, , Japan
Aichi, , Japan
Nara, , Japan
Yamanashi, , Japan
Patients applied
Trial Officials
Toshimitsu Tokimoto
Study Director
AstraZeneca KK
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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