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Observational study on acalabrutinib for chronic lymphocytic leukemia in Italy

Acalabrutinib Real World Italian obSErvational Secondary Data Collection Study of Acalabrutinib in the Treatment of Patients With Chronic Lymphocytic Leukemia.

AstraZeneca · NCT06205498

This study looks at how well acalabrutinib works for adults with chronic lymphocytic leukemia in Italy by tracking their treatment experiences and outcomes over time.

Quick facts

Study typeObservational
Enrollment190 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca (industry)
Drugs / interventionsacalabrutinib
Locations44 sites (Alessandria and 43 other locations)
Trial IDNCT06205498 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the real-world use of acalabrutinib in adult patients with chronic lymphocytic leukemia (CLL) who started treatment between May 2021 and April 2022. It will follow a retrospective cohort of patients across multiple centers in Italy, collecting data from medical records over a maximum period of five years. The primary outcome is the time to discontinuation of acalabrutinib treatment, while secondary outcomes will assess various treatment timelines and patient responses. The study will utilize standardized electronic case report forms to ensure consistent data collection.

Who should consider this trial

Good fit: Ideal candidates include adult patients diagnosed with chronic lymphocytic leukemia who initiated treatment with acalabrutinib during the specified time frame.

Not a fit: Patients who began acalabrutinib treatment outside the specified dates or those with other forms of leukemia may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of acalabrutinib in real-world settings for CLL patients.

How similar studies have performed: Previous studies have shown the efficacy of acalabrutinib in clinical settings, but this observational approach to real-world data is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Alessandria and 43 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Chronic Lymphocytic Leukemia, acalabrutinib, CLL, Observational

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.