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Retention of Acalabrutinib in Patients with Chronic Lymphocytic Leukaemia

Retention Rate of Acalabrutinib in a Non-interventional Setting

Observational AstraZeneca · NCT05645172

This study is trying to see how well patients with Chronic Lymphocytic Leukaemia stick with acalabrutinib treatment over one and two years in Germany and what factors might affect their experience.

Quick facts

Study typeObservational
Enrollment200 (estimated)
Ages18 Years to 99 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsobinutuzumab, acalabrutinib
Locations62 sites (Amberg and 61 other locations)
Trial IDNCT05645172 on ClinicalTrials.gov

What this trial studies

This observational study aims to collect real-world data on the retention rates of patients with Chronic Lymphocytic Leukaemia (CLL) who are prescribed acalabrutinib in Germany. It will assess therapy retention one and two years after treatment initiation, alongside evaluating therapy adherence, treatment efficacy, overall survival, and quality of life. The study will also analyze various factors that may influence therapy retention, including sociodemographic factors, disease characteristics, comorbidities, and psychological aspects of disease perception.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with Chronic Lymphocytic Leukaemia and are starting therapy with acalabrutinib.

Not a fit: Patients who are currently participating in an interventional clinical trial or have contraindications to acalabrutinib treatment will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness and adherence to acalabrutinib treatment for CLL patients.

How similar studies have performed: While this study focuses on real-world data collection, similar observational studies have shown success in understanding treatment retention and adherence in chronic conditions.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Age ≥ 18 years
* Diagnosis of CLL
* Ability to understand the study concept and to regularly complete patient questionnaires from physical, mental, and linguistic perspectives
* Decision to start therapy with acalabrutinib according to the current SmPC. For previously untreated patients as continuous therapy with or without obinutuzumab. OR For patients with at least one prior CLL therapy as continuous monotherapy.
* Provision of signed informed consent form

Exclusion Criteria:

* Current or planned participation in an interventional clinical trial
* Contraindications to treatment with acalabrutinib according to the current SmPC
* Pregnancy or breast feeding
* Disease progression on prior BTKi therapy
* Start of acalabrutinib therapy more than 28 days prior to enrolment

Where this trial is running

Amberg and 61 other locations

+12 more sites — see ClinicalTrials.gov for the full list.

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 → Find more trials like this →
Conditions Chronic Lymphocytic LeukaemiaAcalabrutinib
Last reviewed 2026-06-10 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.