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Real-World data on acalabrutinib for CLL: what happens outside the lab?

NCT ID NCT06170671

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how well the drug acalabrutinib works for people with chronic lymphocytic leukemia (CLL) in real-life settings in Romania. Researchers will collect data from 250 patients over three years to see how long they stay on the drug, why they stop, and how effective it is. The goal is to understand the drug's performance outside of strict 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
acalabrutinib
What this could lead to
If successful, this study could provide valuable insights into how acalabrutinib performs outside of clinical trials, helping doctors make better treatment decisions for CLL patients.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by patient selection and real-world factors, and the study is limited to Romania.

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

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Sep 2028

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

CLL patients routinely initiated on acalabrutinib in front-line or subsequent treatment during the study eligibility window January 2023-December 2024

Ages

18 to 130 years

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: * Adult patients (age \>18 years) with confirmed diagnosis of chronic lymphocytic leukemia/ small lymphocytic lymphoma * Patients initiating front-line or subsequent treatment with acalabrutinib between January 2023 and Dec 2024 according to the national therapeutic protocol * Patients able and willing to provide their written informed consent to participate in the study Exclusion Criteria: * The treatment with acalabrutinib was initiated during an interventional clinical trial * Enrolment performed less than 30 days from start of treatment with acalabrutinib

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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

    Piteşti, Argeş, 110084, Romania

  • Research Site

    Oradea, Bihor County, 410469, Romania

  • Research Site

    Cluj-Napoca, Cluj, 400015, Romania

  • Research Site

    Craiova, Dolj, 200143, Romania

  • Research Site

    Deva, Hunedoara County, 330084, Romania

  • Research Site

    Baia Mare, Maramureş, 430031, Romania

  • Research Site

    Târgu Mureş, Mureș County, 540136, Romania

  • Research Site

    Piatra Neamţ, Neamț County, 610136, Romania

  • Research Site

    Timișoara, Timiș County, 300239, Romania

  • Research Site

    Timișoara, Timiș County, 300254, Romania

  • Research Site

    Focşani, Vrancea, 620034, Romania

  • Research Site

    Brasov, 500052, Romania

  • Research Site

    Bucharest, 20125, Romania

  • Research Site

    Bucharest, 22328, Romania

  • Research Site

    Bucharest, 301710, Romania

  • Research Site

    Bucharest, 30171, Romania

  • Research Site

    Bucharest, 50098, Romania

  • Research Site

    Galati, 800578, Romania

  • Research Site

    Iași, 700483, Romania

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