Observational study on acalabrutinib for chronic lymphocytic leukemia in Italy

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 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.

Why it matters

Who can join: the full rules

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 it's running

• Research Site
  Alessandria, Italy Recruiting
• Research Site
  Ancona, Italy Recruiting
• Research Site
  Bari, Italy Recruiting
• Research Site
  Barletta, Italy Recruiting
• Research Site
  Brindisi, Italy Recruiting
• Research Site
  Campobasso, Italy Recruiting

Study contacts

• Principal investigator: Carola Boccomini — AOU Città della salute e della scienza di Torino - Presidio Molinette
• 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

  This will test whether giving venetoclax intermittently or continuously together with acalabrutinib helps people with previously untreated CLL or SLL.

  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.