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Italian study tracks how long CLL patients stay on acalabrutinib in daily practice

NCT ID NCT06205498

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This observational study follows 151 Italian adults with chronic lymphocytic leukemia (CLL) who started taking acalabrutinib between May 2021 and April 2022. Researchers want to see how long patients continue the drug and why they might stop, providing real-world insights beyond clinical trials. The study does not test a new treatment but observes existing use.

What this could mean

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

Active substance
acalabrutinib (Calquence), a targeted drug for chronic lymphocytic leukemia
What this could lead to
If successful, this study could confirm that acalabrutinib works well in everyday practice, helping doctors make better treatment decisions for CLL patients.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by patient differences. It only looks at treatment duration, not overall survival or cure.

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

151 people

The number who actually took part.

Started

Aug 2023

Expected to finish

Apr 2027

An estimate. End dates often move.

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

Investigators participating in this observational study should include all patients with CLL who initiated treatment with acalabrutinib over the period between May 1st, 2021 and April 30th, 2022, regardless of the treatment status at the time of inclusion. Thus, at the time of enrolment and retrospective data collection, patients may still be on treatment or have stopped treatment for any reason.

Ages

18 years and older

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 All consecutive patients with CLL who received acalabrutinib according to Italian legislation dlg 219/2006 art.125 will be eligible for inclusion in the study, subject to site agreement and patient consent to participate. Patients must meet the following criteria for study entry: 1. Age ≥ 18 years old at the date of consent subscription. 2. Diagnosis of CLL. 3. Treatment of CLL with acalabrutinib at physician's discretion initiated between 1st May 2021 and 30th April 2022. 4. Informed consent to participate in the study and privacy form signed by the patient (or their legal representative). Exclusion Criteria Patients who meet any of the following criteria will be excluded: 1\. Acalabrutinib treatment initiation before 1st May 2021 or after 30th April 2022.

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia

As listed by the trial registrant

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

Chronic lymphocytic leukemia

Contacts and locations

Locations

  • Research Site

    Alessandria, 15121, Italy

  • Research Site

    Ancona, 60126, Italy

  • Research Site

    Bari, 70124, Italy

  • Research Site

    Barletta, 76121, Italy

  • Research Site

    Brindisi, 72100, Italy

  • Research Site

    Campobasso, 86100, Italy

  • Research Site

    Catania, 95100, Italy

  • Research Site

    Catanzaro, 88100, Italy

  • Research Site

    Cosenza, 87100, Italy

  • Research Site

    Crema, 26013, Italy

  • Research Site

    Cuneo, 12100, Italy

  • Research Site

    Foggia, 71122, Italy

  • Research Site

    Frosinone, 03100, Italy

  • Research Site

    Genova, 16132, Italy

  • Research Site

    Lecce, 73100, Italy

  • Research Site

    Messina, 98158, Italy

  • Research Site

    Milan, 20122, Italy

  • Research Site

    Milan, 20132, Italy

  • Research Site

    Monza, 20900, Italy

  • Research Site

    Naples, 80131, Italy

  • Research Site

    Padova, 35128, Italy

  • Research Site

    Pagani, 84016, Italy

  • Research Site

    Perugia, 06132, Italy

  • Research Site

    Pescara, 65124, Italy

  • Research Site

    Ravenna, 48121, Italy

  • Research Site

    Reggio Calabria, 89133, Italy

  • Research Site

    Roma, 00133, Italy

  • Research Site

    Roma, 00161, Italy

  • Research Site

    Roma, 00168, Italy

  • Research Site

    Roma, 00184, Italy

  • Research Site

    Roma, 00189, Italy

  • Research Site

    Rozzano, 20089, Italy

  • Research Site

    Salerno, 84078, Italy

  • Research Site

    San Giovanni Rotondo, 71013, Italy

  • Research Site

    Torino, 10043, Italy

  • Research Site

    Torino, 10073, Italy

  • Research Site

    Torino, 10126, Italy

  • Research Site

    Torino, 10154, Italy

  • Research Site

    Tricase, 73039, Italy

  • Research Site

    Varese, 21100, Italy

  • Research Site

    Viterbo, 01100, Italy

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