Relapsed or Refractory Chronic Lymphocytic Leukemia (Including Small Lymphocytic Lymphoma)NCT04872621
Calquence CLL rr Japan PMS_Japan Post-Marketing Surveillance (PMS) Study - All Patient Investigation
An observational study of Relapsed or Refractory Chronic Lymphocytic Leukemia (Including Small Lymphocytic Lymphoma), run by AstraZeneca at 59 sites in Japan.
Trial summary
To understand the incidence of ADRs of Calquence 100 mg capsules (acalabrutinib) used in patients with relapsed or refractory chronic lymphocytic leukaemia (including small lymphocytic lymphoma) in a real-world post-marketing setting Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Relapsed or Refractory Chronic Lymphocytic Leukemia (Including Small Lymphocytic Lymphoma)
- How many people
- 104 participants
- Where
- 59 sitesJapan
- Study dates
- 30 Jun 2021to 4 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with relapsed or refractory chronic lymphocytic leukaemia (small lymphocytic lymphoma) who are treated with the product
Who may be able to join
- Patients with relapsed or refractory chronic lymphocytic leukemia (small lymphocytic lymphoma) who are treated with the product -
Who cannot join
- None
- -
Trial locations and contacts
59 sites in 1 country.
59 sites in 1 country
Japan59 sites
Research Site
Aichi, D8224C00001
Research Site
Aichi
Research Site
Akita
Research Site
Aomori, D8224C00001
Research Site
Chiba, D8224C00001
Research Site
Chiba
Research Site
Fukui
Research Site
Fukuoka, D8224C00001
Research Site
Fukuoka
Research Site
Gifu
Research Site
Gunma, D8224C00001
Research Site
Gunma
Research Site
Hiroshima, D8224C00001
Research Site
Hiroshima
Research Site
Hokkaido, D8224C00001
Research Site
Hokkaido
Research Site
Hyōgo, D8224C00001
Research Site
Hyōgo
Research Site
Ibaraki, D8224C00001
Research Site
Ibaraki
Research Site
Ishikawa
Research Site
Kagoshima, D8224C00001
Research Site
Kagoshima
Research Site
Kanagawa, D8224C00001
Research Site
Kanagawa
Research Site
Kochi
Research Site
Kumamoto
Research Site
Kyoto, D8224C00001
Research Site
Kyoto
Research Site
Mie
Research Site
Miyagi, D8224C00001
Research Site
Miyagi
Research Site
Miyazaki
Research Site
Nagano
Research Site
Nagasaki, D8224C00001
Research Site
Nagasaki
Research Site
Nara
Research Site
Niigata
Research Site
Numakunai
Research Site
Ōita
Research Site
Okayama
Research Site
Okinawa
Research Site
Osaka, D8224C00001
Research Site
Osaka
Research Site
Saitama, D8224C00001
Research Site
Saitama
Research Site
Shiga, D8224C00001
Research Site
Shiga
Research Site
Shimane
Research Site
Shizuoka, D8224C00001
Research Site
Shizuoka
Research Site
Tokyo, D8224C00001
Research Site
Tokyo
Research Site
Tottori
Research Site
Toyama
Research Site
Wakayama, D8224C00001
Research Site
Wakayama
Research Site
Yamagata
Research Site
Yamaguchi
About this study
Official title: Calquence 100 mg Capsules General Drug Use-Results Study; All Patient Investigation in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (Including Small Lymphocytic Lymphoma)
To understand the incidence of ADRs of Calquence 100 mg capsules (acalabrutinib) used in patients with relapsed or refractory chronic lymphocytic leukaemia (including small lymphocytic lymphoma) in a real-world post-marketing setting
Read the detailed description
To understand the incidence of ADRs of Calquence 100 mg capsules (acalabrutinib) used in patients with relapsed or refractory chronic lymphocytic leukaemia (including small lymphocytic lymphoma) in a real-world post-marketing setting.
This investigation will be conducted for application for re-examination specified in Article 14-4 of the Pharmaceutical Affairs Law. In addition, after launch, the data for a certain number of all cases are collected and the survey is required to be conducted for all cases as conditions of approval.
- Conditions
- Relapsed or Refractory Chronic Lymphocytic Leukemia (Including Small Lymphocytic Lymphoma)
- Medical subject headings
- Recurrence, Leukemia, Lymphocytic, Chronic, B-Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ADRs
the incidence of ADRs related to Calquence Safety specifications: Haemorrhage, infection, bone narrow depression, arrhythmia, ischemic heart disease, tumour lysis syndrome, interstitial lung disease, and second primary malignancy
Measured: 52weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start30 Jun 2021
- Primary completion4 Sep 2024
- Study completion4 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Chronic Lymphocytic Leukemia (Including Small Lymphocytic Lymphoma)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Toshimitsu Tokimoto, Study director, AstraZeneca KK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872621
- Sponsor's protocol ID
- D8224C00001
- Status last verified
- Aug 2025
- First submitted
- 30 Apr 2021
- Last updated
- 2 Sep 2025
- Results posted
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluatedas per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes,indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calquence 100 mg Capsules General Drug Use-Results Study; All Patient Investigation in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (Including Small Lymphocytic Lymphoma)
- ClinicalTrials.gov ID
- NCT04872621
- Acronym / sponsor ID
- D8224C00001
- Conditions
- Relapsed or Refractory Chronic Lymphocytic Leukemia (Including Small Lymphocytic Lymphoma)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 4 Sep 2024 (actual)
- Study completion
- 4 Sep 2024 (actual)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To understand the incidence of ADRs of Calquence 100 mg capsules (acalabrutinib) used in patients with relapsed or refractory chronic lymphocytic leukaemia (including small lymphocytic lymphoma) in a real-world post-marketing setting
Detailed description
To understand the incidence of ADRs of Calquence 100 mg capsules (acalabrutinib) used in patients with relapsed or refractory chronic lymphocytic leukaemia (including small lymphocytic lymphoma) in a real-world post-marketing setting.
This investigation will be conducted for application for re-examination specified in Article 14-4 of the Pharmaceutical Affairs Law. In addition, after launch, the data for a certain number of all cases are collected and the survey is required to be conducted for all cases as conditions of approval.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with relapsed or refractory chronic lymphocytic leukaemia (small lymphocytic lymphoma) who are treated with the product
Key inclusion criteria (1 listed)
- Patients with relapsed or refractory chronic lymphocytic leukemia (small lymphocytic lymphoma) who are treated with the product -
Key exclusion criteria (2 listed)
- None
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of ADRs
Time frame: 52weeks
the incidence of ADRs related to Calquence Safety specifications: Haemorrhage, infection, bone narrow depression, arrhythmia, ischemic heart disease, tumour lysis syndrome, interstitial lung disease, and second primary malignancy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Redacted CSR synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluatedas per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes,indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toshimitsu Tokimoto study director
AstraZeneca KK
59 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsed or Refractory Chronic Lymphocytic Leukemia (Including Small Lymphocytic Lymphoma), run by AstraZeneca at 59 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ADRs (time frame: 52weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.