Retention Rate of Acalabrutinib in a Non-interventional Setting

NCT05645172 · tracked via the Priya Life Science Germany tracker

Sponsor

AstraZeneca

Phase

Observational

Started

2022-12-12

Last updated

2025-12-01

Condition(s) studied

Chronic Lymphocytic Leukaemia (CLL)

Study summary

Retention rate of acalabrutinib in a non-interventional setting. This is a prospective, multicentre, non-interventional study to collect real-world data on retention rates of CLL patients prescribed with acalabrutinib in Germany.

Eligibility

Sex

ALL

Min age

18 Years

Max age

99 Years

Healthy volunteers

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

Primary outcome measure(s)

Retention rate of CLL — 1 year
The primary outcome of this study is the retention rate of CLL patients receiving acalabrutinib in clinical practice after 1 year (= ratio of the number of patients still being prescribed acalabrutinib after 1 year to the number of patients at risk). Cases of death, ongoing treatment interruption, and lost to follow-up will be counted as patients not still being prescribed with acalabrutinib.

Trial sites (61)

Facility	City	Region
Research Site	D Ren	Germany
Research Site	Herrsching am Ammersee	Germany
Research Site	L Rrach	Germany
Research Site	M Nchen	Germany
Research Site	M Nchen	Germany
Research Site	N Rnberg	Germany
Research Site	Neustadt Am R Benberge	Germany
Research Site	Saarbr Cken	Germany
Research Site	Sindelfinden	Germany
Research Site	W Rselen	Germany
Research Site	Amberg	Germany
Research Site	Aschaffenburg	Germany
Research Site	Augsburg	Germany
Research Site	Bad Homburg	Germany
Research Site	Bad Liebenwerda	Germany
Research Site	Bautzen	Germany
Research Site	Berlin	Germany
Research Site	Berlin	Germany
Research Site	Berlin	Germany
Research Site	Bonn	Germany
Research Site	Dachau	Germany
Research Site	Delitzsch	Germany
Research Site	Dessau	Germany
Research Site	Dortmund	Germany
Research Site	Erfurt	Germany
Research Site	Erfurt	Germany
Research Site	Essen	Germany
Research Site	Frankfurt am Main	Germany
Research Site	Frankfurt am Main	Germany
Research Site	Garbsen	Germany
Research Site	Halle	Germany
Research Site	Hanover	Germany
Research Site	Hanover	Germany
Research Site	Heide	Germany
Research Site	Herten	Germany
Research Site	Hof	Germany
Research Site	Kulmbach	Germany
Research Site	Laatzen	Germany
Research Site	Landshut	Germany
Research Site	Lebach	Germany

+ 21 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05645172 on ClinicalTrials.gov ↗ ← All trials in Germany