REAl-world Outcomes in CHronic Lymphocytic Leukemia Patients Receiving Acalabrutinib in Romania

Last updated: April 3, 2025
Sponsor: AstraZeneca
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Chronic Lymphocytic Leukemia

Lymphoproliferative Disorders

Lymphocytic Leukemia, Chronic

Treatment

Non interventional study

Clinical Study ID

NCT06170671
D8220R00055
  • Ages 18-130
  • All Genders

Study Summary

Acalabrutinib received European Medicines Agency approval on November 2020 for for CLL adult patients, either as monotherapy or in combination with obinutuzumab, in previously untreated patients or as monotherapy in patients who have received at least one prior therapy and is reimbursed in Romania since January 2023. In the absence of disease registries or national datasets patient population receiving acalabrutinib in real life setting is not well characterized. The study aims to look into this population outcomes and clinical characteristics having as primary objective time to discontinuation by line of treatment and secondary objectives: reasons for discontinuation, effectiveness of acalabrutinib in real-life practice, baseline clinical and demographic characteristics, treatment patterns and major determinants of treatment discontinuation. The study will retrospectively collect longitudinal data from 250 patients at national level,at pre-defined timepoints for 3 years, from 2 sequential cohorts,1st one enrolled on December 2023 and 2nd one enrolled in December 2024 based on the acalabrutinib start year..

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients (age >18 years) with confirmed diagnosis of chronic lymphocyticleukemia/ small lymphocytic lymphoma

  • Patients initiating front-line or subsequent treatment with acalabrutinib betweenJanuary 2023 and Dec 2024 according to the national therapeutic protocol

  • Patients able and willing to provide their written informed consent to participatein the study

Exclusion

Exclusion Criteria:

  • The treatment with acalabrutinib was initiated during an interventional clinicaltrial

  • Enrolment performed less than 30 days from start of treatment with acalabrutinib

Study Design

Total Participants: 250
Treatment Group(s): 1
Primary Treatment: Non interventional study
Phase:
Study Start date:
December 13, 2023
Estimated Completion Date:
September 30, 2028

Connect with a study center

  • Research Site

    Pitesti, Arges 110084
    Romania

    Site Not Available

  • Research Site

    Oradea, Bihor 410469
    Romania

    Site Not Available

  • Research Site

    Cluj Napoca, Cluj 400015
    Romania

    Site Not Available

  • Research Site

    Craiova, Dolj 200143
    Romania

    Site Not Available

  • Research Site

    Deva, Hunedoara 330084
    Romania

    Site Not Available

  • Research Site

    Baia Mare, Maramures 430031
    Romania

    Site Not Available

  • Research Site

    Targu Mures, Mures 540136
    Romania

    Site Not Available

  • Research Site

    Piatra Neamt, Neamt 610136
    Romania

    Site Not Available

  • Research Site

    Timisoara, Timis 300254
    Romania

    Site Not Available

  • Research Site

    Focsani, Vrancea 620034
    Romania

    Site Not Available

  • Research Site

    Brasov, 500052
    Romania

    Site Not Available

  • Research Site

    Bucuresti, 30171
    Romania

    Site Not Available

  • Research Site

    Galati, 800578
    Romania

    Site Not Available

  • Research Site

    Iasi, 700483
    Romania

    Site Not Available

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