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Search / Trial NCT05665374

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.

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

0 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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