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

NCT ID: NCT06170671

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-13

Study Completion Date

2028-09-30

Brief Summary

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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..

Detailed Description

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Conditions

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Chronic Lymphocytic Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cohort 1

December 2023 - collecting data retrospectively from patients routinely initiated on acalabrutinib between January - December 2023

Non interventional study

Intervention Type DRUG

CLL patients routinely initiated on acalabrutinib by their physician between January 2023 -December 2024. Retrospective secondary data collection

Cohort 2

December 2024-collecting data retrospectively from patients routinely initated on acalabrutinib between January - December 2024

Non interventional study

Intervention Type DRUG

CLL patients routinely initiated on acalabrutinib by their physician between January 2023 -December 2024. Retrospective secondary data collection

Interventions

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Non interventional study

CLL patients routinely initiated on acalabrutinib by their physician between January 2023 -December 2024. Retrospective secondary data collection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients (age \>18 years) with confirmed diagnosis of chronic lymphocytic leukemia/ small lymphocytic lymphoma
* Patients initiating front-line or subsequent treatment with acalabrutinib between January 2023 and Dec 2024 according to the national therapeutic protocol
* Patients able and willing to provide their written informed consent to participate in the study

Exclusion Criteria

* The treatment with acalabrutinib was initiated during an interventional clinical trial
* Enrolment performed less than 30 days from start of treatment with acalabrutinib
Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Piteşti, Argeş, Romania

Site Status

Research Site

Oradea, Bihor County, Romania

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Cluj-Napoca, Cluj, Romania

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Craiova, Dolj, Romania

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Deva, Hunedoara County, Romania

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Baia Mare, Maramureş, Romania

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Târgu Mureş, Mureș County, Romania

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Piatra Neamţ, Neamț County, Romania

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Timișoara, Timiș County, Romania

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Timișoara, Timiș County, Romania

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Focşani, Vrancea, Romania

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Research Site

Brasov, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Research Site

Galati, , Romania

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Research Site

Iași, , Romania

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Countries

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Romania

Other Identifiers

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D8220R00055

Identifier Type: -

Identifier Source: org_study_id