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Spots Global Cancer Trial Database for REAl-world Outcomes in CHronic Lymphocytic Leukemia Patients Receiving Acalabrutinib in Romania

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Trial Identification

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

Official Title: Observational, Secondary Data Collection Study to Describe Acalabrutinib Treatment Outcomes in Chronic Lymphocytic Leukemia Patients in Real-life Setting in Romania

Study ID: NCT06170671

Study Description

Brief 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..

Detailed Description:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Research Site, Oradea, Bihor, Romania

Research Site, Cluj Napoca, Cluj, Romania

Research Site, Craiova, Dolj, Romania

Research Site, Deva, Hunedoara, Romania

Research Site, Baia Mare, Maramures, Romania

Research Site, Targu Mures, Mures, Romania

Research Site, Timisoara, Timis, Romania

Research Site, Timisoara, Timis, Romania

Research Site, Brasov, , Romania

Research Site, Bucuresti, , Romania

Research Site, Bucuresti, , Romania

Research Site, Bucuresti, , Romania

Research Site, Bucuresti, , Romania

Research Site, Iasi, , Romania

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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