NCT05665374

Completed

Calquence CLL 1L Japan PMS _ Japan Post-Marketing Surveillan...

AstraZeneca Source

Compare

Other study identifiers

Sponsor study identifier

D822EC00001

Study Type

observational

Actual enrollment (reported)

67

Locations

1 country

Sites

15

Timeline

Study Start

June 19, 2023

Actual (reported)

Primary Completion

August 20, 2025

Actual (reported)

Study Completion

August 20, 2025

Actual (reported)

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 67 participants
Study completion date: August 20, 2025
Actual (reported)
Listed locations: 1 countries · 15 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
December 16, 2022
Actual (reported)
First Posted
December 27, 2022
Actual (reported)
Study Start
June 19, 2023
Actual (reported)
Primary Completion
August 20, 2025
Actual (reported)
Study Completion
August 20, 2025
Actual (reported)

Last Updated: May 15, 2026
Status Verified: May 2026
Last Update Submitted: May 13, 2026

Conditions

Previously Untreated Chronic Lymphocytic Leukaemia (Including Small Lymphocytic Lymphoma)

Outcome Measures

Primary Outcomes (1)

Incidence of ADRs
the incidence of ADRs related to Calquence Safety Specifications : infection, bone marrow depression
24 weeks

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients with previously untreated chronic lymphocytic leukaemia (including small lymphocytic lymphoma) who are treated with Calquence

You may qualify if:

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.

Sponsors & Collaborators

AstraZeneca
Industrylead

Study Sites (15)

Research Site

Aichi, Japan

Research Site

Chiba, Japan

Research Site

Fukuoka, Japan

Research Site

Hyōgo, Japan

Research Site

Kanagawa, Japan

Research Site

Kyoto, Japan

Research Site

Miyazaki, Japan

Research Site

Study Officials

Toshimitsu Tokimoto
AstraZeneca KK
STUDY DIRECTOR

Enrollment

67 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 16, 2022

First Posted

December 27, 2022

Study Start

June 19, 2023

Actual (reported)

You may not qualify if:

None

Contact the study team to confirm eligibility.

Nagano, Japan

Research Site

Nara, Japan

Research Site

Okayama, Japan

Research Site

Osaka, Japan

Research Site

Saitama, Japan

Research Site

Shizuoka, Japan

Research Site

Tokyo, Japan

Research Site

Yamanashi, Japan

Primary Completion

August 20, 2025

Actual (reported)

Study Completion

August 20, 2025

Actual (reported)

Last Updated

May 15, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing: Will share
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05665374
Data provider: ClinicalTrials.gov
Source updated: 2026-05-15
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:26:39 UTC

Locations

JP(15)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (15)

Related Links

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (15)

Related Links

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations