Retention Rate of Acalabrutinib in a Non-interventional Setting (RETAIN)

AstraZeneca

Status: Active, not recruiting

Conditions: Chronic Lymphocytic Leukaemia (CLL)

Study type: Observational

Funder types: Industry

Identifiers

NCT05645172

D8224R00001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 137 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No 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

Trial design

137 participants in 1 patient group

Cohort 1

Description:

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.