Retention Rate of Acalabrutinib in a Non-interventional Setting

Chronic Lymphocytic Leukaemia (CLL) Clinical Trial

— RETAIN  

Official title:

Retention Rate of Acalabrutinib in a Non-interventional Setting

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05645172
• Other study ID #: D8224R00001
• Status: Recruiting
• Start date: December 12, 2022
• Est. completion date: April 15, 2026

Study information

• Verified date: April 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 15, 2026
• Est. primary completion date: April 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukaemia (CLL)
• Leukemia, Lymphocytic, Chronic, B-Cell

Locations

Country	Name	City	State
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	Dachau
Germany	Research Site	Dortmund
Germany	Research Site	Düren
Germany	Research Site	Erfurt
Germany	Research Site	Erfurt
Germany	Research Site	Frankfurt am Main
Germany	Research Site	Frankfurt am Main
Germany	Research Site	Garbsen
Germany	Research Site	Halle
Germany	Research Site	Halle (Saale)
Germany	Research Site	Hannover
Germany	Research Site	Hannover
Germany	Research Site	Herrsching
Germany	Research Site	Laatzen
Germany	Research Site	Landshut
Germany	Research Site	Lebach
Germany	Research Site	Leipzig
Germany	Research Site	Leipzig
Germany	Research Site	Lörrach
Germany	Research Site	München
Germany	Research Site	München
Germany	Research Site	Naunhof
Germany	Research Site	Neustadt am Rübenberge
Germany	Research Site	Nürnberg
Germany	Research Site	Oldenburg
Germany	Research Site	Paderborn
Germany	Research Site	Pasing
Germany	Research Site	Pirna
Germany	Research Site	Porta Westfalica
Germany	Research Site	Potsdam
Germany	Research Site	Remscheid
Germany	Research Site	Reutlingen
Germany	Research Site	Riesa
Germany	Research Site	Saalfeld
Germany	Research Site	Saarbrücken
Germany	Research Site	Schkeuditz
Germany	Research Site	Schorndorf
Germany	Research Site	Siegburg
Germany	Research Site	Sindelfinden
Germany	Research Site	Straubing
Germany	Research Site	Twistringen
Germany	Research Site	Zittau

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention rate of CLL	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.	1 year
Secondary	Retention rate of CLL	The secondary outcome is the retention rate of CLL patients receiving acalabrutinib in clinical practice after 2 years.	2 years
Secondary	General treatment adherence	General treatment adherence will be assessed over the whole observational period by the self-reported, 8-item structured MMAS-8 questionnaire.	assessed at baseline and 6, 12, and 24 months after start of acalabrutinib treatment
Secondary	reasons for and duration of therapy interruptions	Based on acalabrutinib treatment details, the reasons for and duration of therapy interruptions will be calculated and analysed.	time from first prescription until therapy interruptions; assessed up to 40 months
Secondary	TTD	Based on acalabrutinib treatment details, the TTD, defined as the time from first prescription until the date of last intake or death, whichever occurs first, will be calculated and the reasons for therapy discontinuation will be analysed.	time from start of acalabrutinib treatment until the date of final discontinuation or death; assessed up to 40 months.
Secondary	TTNT	Based on acalabrutinib treatment details, the TTNT, defined as the time of first prescription until start date of the next CLL treatment will be calculated and the reasons for switch of treatment will be analysed. Cases of death will be censored and not considered as TTNT-relevant event.	time from start of acalabrutinib treatment until start of a subsequent CLL treatment; assessed up to 40 months.
Secondary	TTNT-D	Based on acalabrutinib treatment details, the TTNT-D, defined as the time of first prescription until start date of the next CLL treatment or death, whichever occurs first, will be calculated.	time from start of acalabrutinib treatment until start of a subsequent CLL treatment or death; assessed up to 40 months
Secondary	Treatment efficacy and PFS	Treatment efficacy will be analysed by means of the overall treatment response (CR, PR, PRL, judged by the treating physician and recommended to be in accordance with the guidelines of the International Workshop on Chronic Lymphocytic Leukemia (iwCLL), modified for persistent lymphocytosis, the time to and duration of response, the percentage of patients without treatment response (SD, PD), as well as the time of PFS, defined as the time of first prescription until progression of the disease or death by any cause, whichever occurs first.	time from start of acalabrutinib treatment until disease progression or death by any cause, whichever occurs first; assessed up to 40 months.
Secondary	Overall survival	Overall survival will be calculated as the time from first prescription until death by any cause.	time from start of acalabrutinib treatment until death by any cause; assessed up to 40 months.
Secondary	Patient- and disease-specific factors possibly affecting the retention rate	Patient- and disease-specific factors possibly affecting the retention rate will be analysed for associations with the following variables: - Treatment effectiveness (treatment response, PFS)	up to 40 months
Secondary	Healths-related Quality of Life (HRQoL)-QLQ-C30	The QoL, as measured by the self-reported QLQ-C30 questionnaires, will be assessed at baseline and every quarterly regular follow-up visit thereafter until end of observation. The time course of the QoL will be visualised and the mean difference from baseline until 6, 12, and 24 months after start of therapy will be calculated. Clinical significance will be defined as minimal important differences (MIDs) of at least 10 points (in either direction) for total scores or subscales of the QLQ-C30.	Patient questionnaires will becollected at time points synchronised with regular visits during study, assessed up to 40 months
Secondary	Healths-related Quality of Life (HRQoL)-EQ-5D-5L	The QoL, as measured by the self-reported EQ-5D-5L questionnaires, will be assessed at baseline and every quarterly regular follow-up visit thereafter until end of observation. The time course of the QoL will be visualised and the mean difference from baseline until 6, 12, and 24 months after start of therapy will be calculated.	Patient questionnaires will becollected at time points synchronised with regular visits during study, assessed up to 40 months
Secondary	Patient- and disease-specific factors possibly affecting the retention rate	Patient- and disease-specific factors possibly affecting the retention rate will be analysed for associations with the following variables: - Patient- and disease-specific characteristics (sociodemographic data, disease characteristics and severity, comorbidities (CIRS), comedication).	up to 40 months
Secondary	Patient- and disease-specific factors possibly affecting the retention rate	Patient- and disease-specific factors possibly affecting the retention rate will be analysed for associations with the following variables: - Treatment adherence (MMAS-8).	up to 40 months
Secondary	Patient- and disease-specific factors possibly affecting the retention rate (Psychological patient segmentation)	Psychological patient segmentation as determinant for the disease acceptance and disease control will be performed during the baseline visit by using a questionnaire published by Bloem et al. in 2020	at Baseline
Secondary	Patient- and disease-specific factors possibly affecting the retention rate	Patient- and disease-specific factors possibly affecting the retention rate will be analysed for associations with the following variables: - Safety (rate, severity, and duration of SAEs and ADRs)	up to 40 months