Chronic Lymphocytic Leukaemia (CLL)RETAINNCT05645172
Retention Rate of Acalabrutinib in a Non-interventional Setting
An observational study of Chronic Lymphocytic Leukaemia (CLL), run by AstraZeneca at 61 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Lymphocytic Leukaemia (CLL)
- How many people
- 193 participants
- Where
- 61 sitesGermany
- Study dates
- 12 Dec 2022to 15 Apr 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
61 sites in 1 country.
61 sites in 1 country
Germany61 sites
Research Site
Amberg, 92224
Research Site
Aschaffenburg, 63739
Research Site
Augsburg, 86150
Research Site
Bad Homburg, 61352
Research Site
Bad Liebenwerda, 04924
Research Site
Bautzen, 02625
Research Site
Berlin, 10117
Research Site
Berlin, 13055
Research Site
Berlin, 13156
Research Site
Bonn, 53115
Research Site
D Ren, Germany, 52353
Research Site
Dachau, 85221
Research Site
Delitzsch, 04509
Research Site
Dessau, 06487
Research Site
Dortmund, 44263
Research Site
Erfurt, 99084
Research Site
Erfurt, 99085
Research Site
Essen, 45136
Research Site
Frankfurt am Main, 60596
Research Site
Frankfurt am Main, 65929
Research Site
Garbsen, 30823
Research Site
Halle, 06110
Research Site
Hanover, 30161
Research Site
Hanover, 30625
Research Site
Heide, 25746
Research Site
Herrsching am Ammersee, Germany, 82211
Research Site
Herten, 45699
Research Site
Hof, 04509
Research Site
Kulmbach, 95326
Research Site
L Rrach, Germany, 79539
Research Site
Laatzen, 30880
Research Site
Landshut, 72764
Research Site
Lebach, 66822
Research Site
Leipzig, 04103
Research Site
Leipzig, 04289
Research Site
M Nchen, Germany, 80804
Research Site
M Nchen, Germany, 81377
Research Site
Moers, 47441
Research Site
N Rnberg, Germany, 90449
Research Site
Naunhof, 04683
Research Site
Neustadt Am R Benberge, Germany, 31535
Research Site
Oldenburg, 26121
Research Site
Paderborn, 33098
Research Site
Pasing, 81281
Research Site
Pirna, 01796
Research Site
Porta Westfalica, 32457
Research Site
Potsdam, 14482
Research Site
Remscheid, 42859
Research Site
Reutlingen, 72764
Research Site
Riesa, 01589
Research Site
Saalfeld, 07318
Research Site
Saarbr Cken, Germany, 66113
Research Site
Schkeuditz, 04435
Research Site
Schorndorf, 73614
Research Site
Siegburg, 53721
Research Site
Sindelfinden, Germany, 71065
Research Site
Straubing, 94315
Research Site
Twistringen, 27239
Research Site
W Rselen, Germany, 52146
Research Site
Weiden, 92637
Research Site
Zittau, '02763
About this study
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.
Read the 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.
- Conditions
- Chronic Lymphocytic Leukaemia (CLL)
- Keywords
- Acalabrutinib
- Medical subject headings
- Leukemia, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (15)
Retention rate of CLL
The secondary outcome is the retention rate of CLL patients receiving acalabrutinib in clinical practice after 2 years.
Measured: 2 years
General treatment adherence
General treatment adherence will be assessed over the whole observational period by the self-reported, 8-item structured MMAS-8 questionnaire.
Measured: assessed at baseline and 6, 12, and 24 months after start of acalabrutinib treatment
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.
Measured: time from first prescription until therapy interruptions; assessed up to 40 months
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.
Measured: time from start of acalabrutinib treatment until the date of final discontinuation or death; assessed up to 40 months.
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.
Measured: time from start of acalabrutinib treatment until start of a subsequent CLL treatment; assessed up to 40 months.
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.
Measured: time from start of acalabrutinib treatment until start of a subsequent CLL treatment or death; assessed up to 40 months
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.
Measured: time from start of acalabrutinib treatment until disease progression or death by any cause, whichever occurs first; assessed up to 40 months.
Overall survival
Overall survival will be calculated as the time from first prescription until death by any cause.
Measured: time from start of acalabrutinib treatment until death by any cause; assessed up to 40 months.
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)
Measured: up to 40 months
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.
Measured: Patient questionnaires will becollected at time points synchronised with regular visits during study, assessed up to 40 months
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.
Measured: Patient questionnaires will becollected at time points synchronised with regular visits during study, assessed up to 40 months
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).
Measured: up to 40 months
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).
Measured: up to 40 months
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
Measured: at Baseline
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)
Measured: up to 40 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start12 Dec 2022
- Primary completion15 Apr 2027 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic Leukaemia (CLL)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645172
- Sponsor's protocol ID
- D8224R00001
- Acronym
- RETAIN
- Status last verified
- Oct 2026
- First submitted
- 10 Nov 2022
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.