Observational study of acalabrutinib for chronic lymphocytic leukaemia in the UK

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 gather real-world clinical data on patients with chronic lymphocytic leukaemia (CLL) who have received acalabrutinib as part of the Early Access Programme in the UK. Physicians treating these patients will recruit participants, and clinical data will be extracted from their medical records in compliance with local regulations. The study will estimate progression-free survival, overall survival, response rates, and healthcare resource utilization among treatment-naïve patients who started acalabrutinib between April 2020 and April 2021.

Why it matters

Who can join: the full rules

The study population will include treatment-naïve patients with chronic lymphocytic lymphoma (CLL)\* who meet the following inclusion criteria:

* Treatment-naïve CLL patients who were initiated on acalabrutinib as part of the UK Early Access Programme
* Received their first dose of acalabrutinib between 1 April 2020 and 1 April 2021
* Patients aged ≥18 years old

  * Note: patients later found to have small lymphocytic lymphoma (SLL) may also be included in the EAP.

Exclusion Criteria:

\- None listed in study protocol

Where it's running

• Research Site
  Aylesbury, United Kingdom Recruiting
• Research Site
  Bath, United Kingdom Recruiting
• Research Site
  Birmingham, United Kingdom Recruiting
• Research Site
  Bournemouth, United Kingdom Recruiting
• Research Site
  Cardiff, United Kingdom Recruiting
• Research Site
  Cornwall, United Kingdom Recruiting

Study contacts

• Principal investigator: Toby A Eyre — Department of Clinical Haematology, Oxford University Hospitals NHS Foundation Trust, Oxford, UK
• 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.

• Acalabrutinib and Venetoclax for relapsed CLL/SLL after initial BTKi+BCL2i response

  This trial tests a finite-duration combination of acalabrutinib and venetoclax in adults whose CLL or SLL has relapsed after a first-line BTKi+BCL2i therapy and who had at least 2 years of response.

  Recruiting at 16 sites Phase 2 AstraZeneca · Boston, Massachusetts and 46 other locations · NCT07024706

• Ibrutinib and Venetoclax in CLL/SLL: Long-Term Outcomes After Frontline CAPTIVATE

  This study follows people with CLL or SLL who previously received the ibrutinib plus venetoclax combination in CAPTIVATE to see how they do over time and what treatments they need if the disease returns.

  Recruiting European Research Initiative on CLL · Milan · NCT07774390

• Impact of Targeted Therapy on Cancer-Related Cognitive Impairment

  This study checks whether brain health and well‑being differ for people with leukemia who are starting or on TKI therapy compared with similar individuals without cancer or TKI exposure.

  Recruiting University of Rochester · Rochester, New York · NCT07638007

• 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

• BTK degrader plus BCL-2 inhibitor in untreated CLL/SLL

  This phase 2 study tests whether the BTK degrader BGB-16673 together with sonrotoclax can help people with newly diagnosed CLL/SLL.

  Recruiting Phase 2 M.D. Anderson Cancer Center · Houston, Texas · NCT07508995

• Immune profiling during first-line pirtobrutinib treatment for CLL/SLL

  This will test pirtobrutinib as a first treatment for adults with CLL or SLL and see how it changes immune cells in the blood and lymph nodes.

  Recruiting Early Phase 1 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07428707

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.