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Calquence capsules pass Real-World safety check in CLL patients

NCT ID NCT05665374

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study looked at the safety of Calquence (acalabrutinib) capsules in 67 people with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma. Researchers tracked side effects like infections and bone marrow problems during everyday use. The goal was to understand how safe the drug is outside of controlled clinical trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Calquence (acalabrutinib) capsules 100 mg
What this could lead to
If successful, this study could confirm that Calquence is safe and manageable for people with untreated CLL in everyday medical practice.
What could go wrong
This is a small, completed safety study, not a large trial testing how well the drug works. Side effects like infections or bone marrow problems may still occur.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

67 people

The number who actually took part.

Started

Jun 2023

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 \-

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia chronic lymphocytic leukemia/small lymphocytic lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Previously untreated chronic lymphocytic leukaemia (including small lymphocytic lymphoma)

Contacts and locations

Locations

  • 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

    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