Acalabrutinib in first-line CLL in Spain: real-world observation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational, non-interventional study collecting real-world data on adults with CLL who begin acalabrutinib as their first-line therapy in Spain. It uses ambispective data (retrospective and prospective) to describe treatment patterns, outcomes, and safety in routine clinical practice. Two cohorts are included: cohort 1 tracks patients who started acalabrutinib in the year before site initiation, either as treatment-naïve or after intolerance to an initial BTK inhibitor, and cohort 2 examines first-line fixed-duration acalabrutinib with venetoclax according to official approvals. Data collection extends up to about 32 months for cohort 1 and ~25 months after the last patient enrollment for cohort 2. Participation is based on physician decision and local practice, with consent for living patients where required.

Why it matters

Who can join: the full rules

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.

Where it's running

• Research Site
  Almería, Andalusia, Spain Recruiting
• Research Site
  Córdoba, Andalusia, Spain Recruiting
• Research Site
  Granada, Andalusia, Spain Recruiting
• Research Site
  Seville, Andalusia, Spain Recruiting
• Research Site
  Zaragoza, Aragon, Spain Recruiting
• Research Site
  San Cristóbal de La Laguna, Canary Islands, Spain Recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Tafasitamab plus Acalabrutinib and Venetoclax for newly treated CLL/SLL

  This phase II study tests a combination of tafasitamab, acalabrutinib, and venetoclax in adults who are newly diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma to see if it is safe and effective.

  Recruiting at 2 sites Phase 2 City of Hope Medical Center · Duarte, California and 1 other locations · NCT07582159

• Acalabrutinib for CLL in routine care in Belarus

  This project will see how well acalabrutinib works and how safe it is for adults with chronic lymphocytic leukemia treated in routine clinical practice in Belarus.

  Recruiting at 3 sites AstraZeneca · Grodno and 3 other locations · NCT07288515

• Sonrotoclax plus zanubrutinib versus venetoclax plus acalabrutinib for adults with untreated CLL

  This tests whether a fixed-duration combination of sonrotoclax plus zanubrutinib works as well as or better than venetoclax plus acalabrutinib for adults with previously untreated CLL who need treatment.

  Recruiting at 114 sites Phase 3 BeOne Medicines · Duarte, California and 114 other locations · NCT07277231

• Intermittent versus continuous venetoclax with acalabrutinib in CLL/SLL

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  Recruiting Phase 2 University of Cincinnati · Cincinnati, Ohio · NCT07014917

• Quality of life for people with CLL treated with acalabrutinib in France (PLATON database retrospective analysis)

  This project will test how quality of life changes during the first 12 months in adults with CLL who start acalabrutinib in real-world care in France.

  Recruiting AstraZeneca · Saint-Affrique · NCT06548152

• Evaluating the risk of tumor lysis syndrome in adults with chronic lymphocytic leukemia receiving venetoclax with obinutuzumab or acalabrutinib

  This study is testing if the combination of venetoclax with either obinutuzumab or acalabrutinib is safe for adults with untreated chronic lymphocytic leukemia.

  Recruiting at 69 sites Phase 3 AbbVie · Tucson, Arizona and 69 other locations · NCT06428019

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.