Study identifier:D8224R00001
ClinicalTrials.gov identifier:NCT05645172
EudraCT identifier:N/A
CTIS identifier:N/A
Retention rate of acalabrutinib in a non-interventional setting
Chronic lymphocytic leukaemia (CLL)
Phase 4
No
-
All
200
Observational
18 Years - 99 Years
Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 Mar 2025 by AstraZeneca
AstraZeneca
-
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.
This observational study will prospectively assess acalabrutinib therapy retention of CLL patients one year and 2 years after treatment initiation with acalabrutinib in routine clinical practice. Furthermore, therapy adherence, treatment efficacy, overall survival, and QoL to analyse the possible influence of psychological aspects of the patient-based disease perception, a four-group-segmentation for acceptance and perceived control of the health state will be conducted. Finally, disease-, treatment-, and patient-specific factors possibly affecting therapy retention will be analysed: sociodemographic factors, disease and treatment characteristics, comorbidities, therapy adherence, treatment effectiveness, safety, QoL, and psychological segmentation.
Location
Status
Location
Zittau, Germany, Germany, `02763
Status
Recruiting
Location
Aschaffenburg, Germany, Germany, 63739
Status
Recruiting
Location
Leipzig, Germany, Germany, 04289
Status
Recruiting
Location
Hannover, Germany, Germany, 30161
Status
Recruiting
Location
M nchen, Germany, Germany, 81377
Status
Recruiting
Location
Leipzig, Germany, Germany, 04103
Status
Recruiting
Location
Bad Homburg, Germany, Germany, 61352
Status
Recruiting
Location
L rrach, Germany, Germany, 79539
Status
Recruiting
Arms | Assigned Interventions |
---|---|
Cohort 1 adult CLL patients (≥ 18 years of age) newly prescribed with acalabrutinib according to clinical routine will be included independent of the patient age, disease stage, existence of genetic risk factors, comorbidities, therapy line, and of the application as combination therapy with obinutuzumab or as monotherapy. | - |
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