Retention Rate of Acalabrutinib in a Non-interventional Setting
RETAIN
1 other identifier
observational
137
1 country
61
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2022
Longer than P75 for all trials
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2022
CompletedFirst Posted
Study publicly available on registry
December 9, 2022
CompletedStudy Start
First participant enrolled
December 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 15, 2026
December 1, 2025
November 1, 2025
3.8 years
November 10, 2022
November 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (15)
Retention rate of CLL
2 years
General treatment adherence
assessed at baseline and 6, 12, and 24 months after start of acalabrutinib treatment
reasons for and duration of therapy interruptions
time from first prescription until therapy interruptions; assessed up to 40 months
TTD
time from start of acalabrutinib treatment until the date of final discontinuation or death; assessed up to 40 months.
TTNT
time from start of acalabrutinib treatment until start of a subsequent CLL treatment; assessed up to 40 months.
- +10 more secondary outcomes
Study Arms (1)
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (61)
Research Site
D Ren, Germany, 52353, Germany
Research Site
Herrsching am Ammersee, Germany, 82211, Germany
Research Site
L Rrach, Germany, 79539, Germany
Research Site
M Nchen, Germany, 80804, Germany
Research Site
M Nchen, Germany, 81377, Germany
Research Site
N Rnberg, Germany, 90449, Germany
Research Site
Neustadt Am R Benberge, Germany, 31535, Germany
Research Site
Saarbr Cken, Germany, 66113, Germany
Research Site
Sindelfinden, Germany, 71065, Germany
Research Site
W Rselen, Germany, 52146, Germany
Research Site
Amberg, 92224, Germany
Research Site
Aschaffenburg, 63739, Germany
Research Site
Augsburg, 86150, Germany
Research Site
Bad Homburg, 61352, Germany
Research Site
Bad Liebenwerda, 04924, Germany
Research Site
Bautzen, 02625, Germany
Research Site
Berlin, 10117, Germany
Research Site
Berlin, 13055, Germany
Research Site
Berlin, 13156, Germany
Research Site
Bonn, 53115, Germany
Research Site
Dachau, 85221, Germany
Research Site
Delitzsch, 04509, Germany
Research Site
Dessau, 06487, Germany
Research Site
Dortmund, 44263, Germany
Research Site
Erfurt, 99084, Germany
Research Site
Erfurt, 99085, Germany
Research Site
Essen, 45136, Germany
Research Site
Frankfurt am Main, 60596, Germany
Research Site
Frankfurt am Main, 65929, Germany
Research Site
Garbsen, 30823, Germany
Research Site
Halle, 06110, Germany
Research Site
Hanover, 30161, Germany
Research Site
Hanover, 30625, Germany
Research Site
Heide, 25746, Germany
Research Site
Herten, 45699, Germany
Research Site
Hof, 04509, Germany
Research Site
Kulmbach, 95326, Germany
Research Site
Laatzen, 30880, Germany
Research Site
Landshut, 72764, Germany
Research Site
Lebach, 66822, Germany
Research Site
Leipzig, 04103, Germany
Research Site
Leipzig, 04289, Germany
Research Site
Moers, 47441, Germany
Research Site
Naunhof, 04683, Germany
Research Site
Oldenburg, 26121, Germany
Research Site
Paderborn, 33098, Germany
Research Site
Pasing, 81281, Germany
Research Site
Pirna, 01796, Germany
Research Site
Porta Westfalica, 32457, Germany
Research Site
Potsdam, 14482, Germany
Research Site
Remscheid, 42859, Germany
Research Site
Reutlingen, 72764, Germany
Research Site
Riesa, 01589, Germany
Research Site
Saalfeld, 07318, Germany
Research Site
Schkeuditz, 04435, Germany
Research Site
Schorndorf, 73614, Germany
Research Site
Siegburg, 53721, Germany
Research Site
Straubing, 94315, Germany
Research Site
Twistringen, 27239, Germany
Research Site
Weiden, 92637, Germany
Research Site
Zittau, '02763, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2022
First Posted
December 9, 2022
Study Start
December 12, 2022
Primary Completion (Estimated)
October 15, 2026
Study Completion (Estimated)
October 15, 2026
Last Updated
December 1, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
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.