Study identifier:D8220R00021
ClinicalTrials.gov identifier:NCT04746950
EudraCT identifier:N/A
CTIS identifier:N/A
ALICIA (Observational prospective study of acalabrutinib in CLL therapy in real clinical practice in Russia)
Chronic Lymphocytic Leukemia
N/A
No
-
All
90
Observational
18 Years - n/a
Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 Dec 2024 by AstraZeneca
AstraZeneca
-
This is a multicenter non-interventional observational study conducted with a single hand arm to collect real-world data. In this study, commercially available acalabrutinib will be used as prescribed treatment for CLL as per the treating physician’s best clinical judgement. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice. A multi-center collaborative effort in 15 centers selected from regions within Russia will help capture more patients into the database, rather than limiting the data to a single institution. This will be critical for: • increasing database sample size • reducing bias (single institution bias) • increasing result’s generalizability to the whole Russian population Being an observational study, only data available from routine clinical practice and standard of care (SoC), in line with national and international laws and regulations, will be recorded. Patients will be treated according to prescribing information, with visit frequency and assessments performed according to routine medical practice and SoC. Only data corresponding to these visits and assessments will be collected as part of the study. Data for the study will be transcribed and entered into an electronic Case Report Form (eCRF) from the patient’s medical records. The site investigator will be responsible for ensuring that all required data is collected and entered into the eCRF with the involvement of clinical research organization
Location
Location
Moscow, Moscow region, Russian Federation, 125284
Location
Moscow, Moscow region, Russian Federation, 129110
Location
Novosibirsk, Novosibirsk region, Russian Federation, 630091
Location
Saint Petersburg, Leningrad Region, Russian Federation, 198205
Location
Khabarovsk, Khabarovsk region, Russian Federation, 680009
Location
Yakutsk, Sakha Republic, Russian Federation, 677008
Location
Krasnoyarsk, Krasnoyarsk region, Russian Federation, 660022
Location
Saratov, Saratov region, Russian Federation, 410028
Arms | Assigned Interventions |
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