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New study tracks Acalabrutinib's Real-World success in CLL patients

NCT ID NCT05999877

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 05, 2026 · Updated 3 times

Summary

This study follows 192 people with chronic lymphocytic leukemia (CLL) in Spain who started taking acalabrutinib for the first time. Researchers want to see how many patients stay on the drug for at least 24 months and how it works in different groups, like those new to treatment or switching due to side effects from an older drug. The goal is to understand real-world outcomes, not to test a new treatment.

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 could show that acalabrutinib is a well-tolerated and effective first-line treatment for chronic lymphocytic leukemia, helping patients stay on therapy longer.
What could go wrong
This is an observational study, not a controlled trial, so results may not prove cause and effect. It only includes patients in Spain, so findings may not apply to other populations.

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

192 people

The number who actually took part.

Started

Jul 2023

Expected to finish

Mar 2029

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

The study aims to include approximately 315 patients in the cohort 1 and 103 patients in the cohort 2 who started acalabrutinib for the first time for the treatment of their CLL. To minimize selection biases, all patients (alive or deceased) identified on acalabrutinib will be eligible for inclusion into the study. These patients will be included from approximately 50 hospitals distributed throughout Spain.

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: * Age ≥18 years old at starting acalabrutinib treatment. * Diagnosis of CLL. * Start of acalabrutinib treatment (index date) as per the CLL SmPC: * in treatment-naïve CLL patients or those switching in first-line between first-generation BTK inhibitor to acalabrutinib due to intolerance in absence of progression according to routine clinical practice within the year before the first site initiation visit (cohort 1). * in treatment-naïve CLL patients for the fixed-duration treatment combination of acalabrutinib plus venetoclax (with or without obinutuzumab) according to routine clinical practice from the EMA approval (i.e., 2 June 2025) (cohort 2). Decision to administer acalabrutinib must be made and documented prior to inclusion into the study and must follow local clinical practice. * Informed consent (for alive patients). Exclusion Criteria: * Enrolled in any clinical trial during acalabrutinib treatment. * Patients who are unable to understand the study and its questionnaires due to insufficient knowledge of the Spanish language or their health status.

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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

    Almería, Andalusia, 4009, Spain

  • Research Site

    Córdoba, Andalusia, 14004, Spain

  • Research Site

    Granada, Andalusia, 18014, Spain

  • Research Site

    Jaén, Andalusia, 23007, Spain

  • Research Site

    Marbella, Andalusia, 29603, Spain

  • Research Site

    Málaga, Andalusia, 29010, Spain

  • Research Site

    Seville, Andalusia, 41013, Spain

  • Research Site

    Zaragoza, Aragon, 50009, Spain

  • Research Site

    Palma de Mallorca, Balearic Islands, 7010, Spain

  • Research Site

    Palma de Mallorca, Balearic Islands, 7198, Spain

  • Research Site

    Las Palmas de Gran Canaria, Canary Islands, 35016, Spain

  • Research Site

    Las Palmas de Gran Canaria, Canary Islands, 35019, Spain

  • Research Site

    San Cristóbal de La Laguna, Canary Islands, 38320, Spain

  • Research Site

    Santander, Cantabria, 39008, Spain

  • Research Site

    Salamanca, Castille and León, 37007, Spain

  • Research Site

    Segovia, Castille and León, 40002, Spain

  • Research Site

    Valladolid, Castille and León, 47003, Spain

  • Research Site

    Valladolid, Castille and León, 47012, Spain

  • Research Site

    Guadalajara, Castille-La Mancha, 19002, Spain

  • Research Site

    Toledo, Castille-La Mancha, 45004, Spain

  • Research Site

    Barcelona, Catalonia, 8003, Spain

  • Research Site

    Barcelona, Catalonia, 8025, Spain

  • Research Site

    Barcelona, Catalonia, 8035, Spain

  • Research Site

    Barcelona, Catalonia, 8036, Spain

  • Research Site

    Granollers, Catalonia, 8402, Spain

  • Research Site

    L'Hospitalet de Llobregat, Catalonia, 8908, Spain

  • Research Site

    Lleida, Catalonia, 25198, Spain

  • Research Site

    Terrassa, Catalonia, 8221, Spain

  • Research Site

    Ourense, Galicia, 32005, Spain

  • Research Site

    Santiago de Compostela, Galicia, 15706, Spain

  • Research Site

    Vigo, Galicia, 36312, Spain

  • Research Site

    Madrid, Madrid, 28006, Spain

  • Research Site

    Madrid, Madrid, 28031, Spain

  • Research Site

    Madrid, Madrid, 28034, Spain

  • Research Site

    Madrid, Madrid, 28040, Spain

  • Research Site

    Madrid, Madrid, 28041, Spain

  • Research Site

    Madrid, Madrid, 28046, Spain

  • Research Site

    Madrid, Madrid, 28905, Spain

  • Research Site

    Madrid, Madrid, 28911, Spain

  • Research Site

    Majadahonda, Madrid, 28222, Spain

  • Research Site

    El Palmar, Murcia, 30120, Spain

  • Research Site

    Murcia, Murcia, 30008, Spain

  • Research Site

    Oviedo, Principality of Asturias, 33011, Spain

  • Research Site

    Alicante, Valencia, 3010, Spain

  • Research Site

    Valencia, Valencia, 46010, Spain

  • Research Site

    Valencia, Valencia, 46014, Spain

  • Research Site

    Valencia, Valencia, 46026, Spain

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