Clinical trial NCT05645172: Retention Rate of Acalabrutinib in a Non-interventional Setting
Official title: Retention Rate of Acalabrutinib in a Non-interventional Setting
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Lymphocytic Leukaemia (CLL)
Keywords: Acalabrutinib
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2022-12-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CLL patients with a newly initiated acalabrutinib treatment in routine clinical practice are planned to be included from approximately 75 sites in Germany over a recruitment period of 16 months.

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Retention rate of CLL
timeFrame: 1 year
Secondary outcomes:
measure: Retention rate of CLL
timeFrame: 2 years
measure: General treatment adherence
timeFrame: assessed at baseline and 6, 12, and 24 months after start of acalabrutinib treatment
measure: reasons for and duration of therapy interruptions
timeFrame: time from first prescription until therapy interruptions; assessed up to 40 months
measure: TTD
timeFrame: time from start of acalabrutinib treatment until the date of final discontinuation or death; assessed up to 40 months.
measure: TTNT
timeFrame: time from start of acalabrutinib treatment until start of a subsequent CLL treatment; assessed up to 40 months.
measure: TTNT-D
timeFrame: time from start of acalabrutinib treatment until start of a subsequent CLL treatment or death; assessed up to 40 months
measure: Treatment efficacy and PFS
timeFrame: time from start of acalabrutinib treatment until disease progression or death by any cause, whichever occurs first; assessed up to 40 months.
measure: Overall survival
timeFrame: time from start of acalabrutinib treatment until death by any cause; assessed up to 40 months.
measure: Patient- and disease-specific factors possibly affecting the retention rate
timeFrame: up to 40 months
measure: Healths-related Quality of Life (HRQoL)-QLQ-C30
timeFrame: Patient questionnaires will becollected at time points synchronised with regular visits during study, assessed up to 40 months
measure: Healths-related Quality of Life (HRQoL)-EQ-5D-5L
timeFrame: Patient questionnaires will becollected at time points synchronised with regular visits during study, assessed up to 40 months
measure: Patient- and disease-specific factors possibly affecting the retention rate
timeFrame: up to 40 months
measure: Patient- and disease-specific factors possibly affecting the retention rate
timeFrame: up to 40 months
measure: Patient- and disease-specific factors possibly affecting the retention rate (Psychological patient segmentation)
timeFrame: at Baseline
measure: Patient- and disease-specific factors possibly affecting the retention rate
timeFrame: up to 40 months
Other outcomes:
Locations:
city: Amberg
country: Germany
facility: Research Site
city: Aschaffenburg
country: Germany
facility: Research Site
city: Augsburg
country: Germany
facility: Research Site
city: Bad Homburg
country: Germany
facility: Research Site
city: Bad Liebenwerda
country: Germany
facility: Research Site
city: Bautzen
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bonn
country: Germany
facility: Research Site
city: D Ren
country: Germany
facility: Research Site
city: Dachau
country: Germany
facility: Research Site
city: Delitzsch
country: Germany
facility: Research Site
city: Dessau
country: Germany
facility: Research Site
city: Dortmund
country: Germany
facility: Research Site
city: Erfurt
country: Germany
facility: Research Site
city: Erfurt
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Frankfurt am Main
country: Germany
facility: Research Site
city: Frankfurt am Main
country: Germany
facility: Research Site
city: Garbsen
country: Germany
facility: Research Site
city: Halle (Saale)
country: Germany
facility: Research Site
city: Halle
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Heide
country: Germany
facility: Research Site
city: Herrsching
country: Germany
facility: Research Site
city: Herten
country: Germany
facility: Research Site
city: Hof
country: Germany
facility: Research Site
city: Kulmbach
country: Germany
facility: Research Site
city: L Rrach
country: Germany
facility: Research Site
city: Laatzen
country: Germany
facility: Research Site
city: Landshut
country: Germany
facility: Research Site
city: Lebach
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: M Nchen
country: Germany
facility: Research Site
city: M Nchen
country: Germany
facility: Research Site
city: Moers
country: Germany
facility: Research Site
city: N Rnberg
country: Germany
facility: Research Site
city: Naunhof
country: Germany
facility: Research Site
city: Neustadt Am R Benberge
country: Germany
facility: Research Site
city: Oldenburg
country: Germany
facility: Research Site
city: Paderborn
country: Germany
facility: Research Site
city: Pasing
country: Germany
facility: Research Site
city: Pirna
country: Germany
facility: Research Site
city: Porta Westfalica
country: Germany
facility: Research Site
city: Potsdam
country: Germany
facility: Research Site
city: Remscheid
country: Germany
facility: Research Site
city: Reutlingen
country: Germany
facility: Research Site
city: Riesa
country: Germany
facility: Research Site
city: Saalfeld
country: Germany
facility: Research Site
city: Saarbr Cken
country: Germany
facility: Research Site
city: Schkeuditz
country: Germany
facility: Research Site
city: Schorndorf
country: Germany
facility: Research Site
city: Siegburg
country: Germany
facility: Research Site
city: Sindelfinden
country: Germany
facility: Research Site
city: Straubing
country: Germany
facility: Research Site
city: Twistringen
country: Germany
facility: Research Site
city: W Rselen
country: Germany
facility: Research Site
city: Weiden
country: Germany
facility: Research Site
city: Zittau
country: Germany
facility: Research Site
Study officials:
References: