Retention Rate of Acalabrutinib in a Non-interventional Setting

Last updated: April 28, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Lymphocytic Leukemia

Lymphocytic Leukemia, Chronic

Treatment

N/A

Clinical Study ID

NCT05645172
D8224R00001
  • Ages 18-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years

  • Diagnosis of CLL

  • Ability to understand the study concept and to regularly complete patientquestionnaires from physical, mental, and linguistic perspectives

  • Decision to start therapy with acalabrutinib according to the current SmPC. Forpreviously untreated patients as continuous therapy with or without obinutuzumab. ORFor patients with at least one prior CLL therapy as continuous monotherapy.

  • Provision of signed informed consent form

Exclusion

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

Total Participants: 200
Study Start date:
December 12, 2022
Estimated Completion Date:
October 15, 2026

Study 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.

Connect with a study center

  • Research Site

    Amberg, 92224
    Germany

    Active - Recruiting

  • Research Site

    Aschaffenburg, 63739
    Germany

    Active - Recruiting

  • Research Site

    Augsburg, 86150
    Germany

    Active - Recruiting

  • Research Site

    Bad Homburg, 61352
    Germany

    Active - Recruiting

  • Research Site

    Bad Liebenwerda, 4924
    Germany

    Active - Recruiting

  • Research Site

    Bautzen, 2625
    Germany

    Active - Recruiting

  • Research Site

    Berlin, 13055
    Germany

    Active - Recruiting

  • Research Site

    Bonn, 53115
    Germany

    Site Not Available

  • Research Site

    D Ren, 52353
    Germany

    Active - Recruiting

  • Research Site

    Dachau, 85221
    Germany

    Site Not Available

  • Research Site

    Delitzsch, 04509
    Germany

    Active - Recruiting

  • Research Site

    Dessau, 06487
    Germany

    Site Not Available

  • Research Site

    Dortmund, 44263
    Germany

    Active - Recruiting

  • Research Site

    Duren, 52353
    Germany

    Site Not Available

  • Research Site

    Düren, 52353
    Germany

    Site Not Available

  • Research Site

    Erfurt, 99084
    Germany

    Site Not Available

  • Research Site

    Essen, 45136
    Germany

    Active - Recruiting

  • Research Site

    Frankfurt am Main, 60596
    Germany

    Active - Recruiting

  • Research Site

    Garbsen, 30823
    Germany

    Active - Recruiting

  • Research Site

    Halle, 06110
    Germany

    Active - Recruiting

  • Research Site

    Halle (Saale), 06110
    Germany

    Site Not Available

  • Research Site

    Hannover, 30625
    Germany

    Active - Recruiting

  • Research Site

    Heide, 25746
    Germany

    Active - Recruiting

  • Research Site

    Herrsching, 82211
    Germany

    Active - Recruiting

  • Research Site

    Herten, 45699
    Germany

    Site Not Available

  • Research Site

    Hof, 04509
    Germany

    Site Not Available

  • Research Site

    Kulmbach, 95326
    Germany

    Active - Recruiting

  • Research Site

    L Rrach, 79539
    Germany

    Active - Recruiting

  • Research Site

    Laatzen, 30880
    Germany

    Site Not Available

  • Research Site

    Landshut, 72764
    Germany

    Active - Recruiting

  • Research Site

    Lebach, 66822
    Germany

    Active - Recruiting

  • Research Site

    Leipzig, 4103
    Germany

    Active - Recruiting

  • Research Site

    Lorrach, 79539
    Germany

    Site Not Available

  • Research Site

    Lörrach, 79539
    Germany

    Site Not Available

  • Research Site

    M Nchen, 81377
    Germany

    Active - Recruiting

  • Research Site

    Moers, 47441
    Germany

    Site Not Available

  • Research Site

    Munchen, 80804
    Germany

    Site Not Available

  • Research Site

    München, 80804
    Germany

    Site Not Available

  • Research Site

    N Rnberg, 90449
    Germany

    Site Not Available

  • Research Site

    Naunhof, 4683
    Germany

    Active - Recruiting

  • Research Site

    Neustadt Am R Benberge, 31535
    Germany

    Active - Recruiting

  • Research Site

    Neustadt am Rubenberge, 31535
    Germany

    Site Not Available

  • Research Site

    Neustadt am Rübenberge, 31535
    Germany

    Site Not Available

  • Research Site

    Nurnberg, 90449
    Germany

    Site Not Available

  • Research Site

    Nürnberg, 90449
    Germany

    Site Not Available

  • Research Site

    Oldenburg, 26121
    Germany

    Active - Recruiting

  • Research Site

    Paderborn, 33098
    Germany

    Active - Recruiting

  • Research Site

    Pasing, 81281
    Germany

    Active - Recruiting

  • Research Site

    Pirna, 01796
    Germany

    Active - Recruiting

  • Research Site

    Porta Westfalica, 32457
    Germany

    Active - Recruiting

  • Research Site

    Potsdam, 14482
    Germany

    Active - Recruiting

  • Research Site

    Remscheid, 42859
    Germany

    Active - Recruiting

  • Research Site

    Reutlingen, 72764
    Germany

    Active - Recruiting

  • Research Site

    Riesa, 01589
    Germany

    Active - Recruiting

  • Research Site

    Saalfeld, 07318
    Germany

    Active - Recruiting

  • Research Site

    Saarbr Cken, 66113
    Germany

    Active - Recruiting

  • Research Site

    Saarbrucken, 66113
    Germany

    Site Not Available

  • Research Site

    Saarbrücken, 66113
    Germany

    Site Not Available

  • Research Site

    Schkeuditz, 04435
    Germany

    Site Not Available

  • Research Site

    Schorndorf, 73614
    Germany

    Site Not Available

  • Research Site

    Siegburg, 53721
    Germany

    Active - Recruiting

  • Research Site

    Sindelfinden, 71065
    Germany

    Active - Recruiting

  • Research Site

    Straubing, 94315
    Germany

    Active - Recruiting

  • Research Site

    Twistringen, 27239
    Germany

    Site Not Available

  • Research Site

    W Rselen, 52146
    Germany

    Site Not Available

  • Research Site

    Weiden, 92637
    Germany

    Active - Recruiting

  • Research Site

    Zittau, 2763
    Germany

    Active - Recruiting

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