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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05645172
Other study ID # D8224R00001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 12, 2022
Est. completion date April 15, 2026

Study information

Verified date May 2024
Source AstraZeneca
Contact AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479
Email information.center@astrazeneca.com
Is FDA regulated No
Health authority
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

Study Design


Related Conditions & MeSH terms


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 Dessau
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 Weiden
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
See also
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Terminated NCT02273856 - Multicentre Registry of Treatments and Outcomes in Patients With Chronic Lymphocytic Leukaemia (CLL) Or Indolent Non Hodgkin's Lymphoma (iNHL) N/A