ALICIA (Acalabrutinib in CLL Therapy)
Study Details
Study Description
Brief Summary
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:
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increasing database sample size
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reducing bias (single institution bias)
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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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- • progression-free survival (rwPFS) in patients with CLL who are treated with acalabrutinib in clinical practice in Russia [Up to 2 years]
- • incidence of adverse events and serious adverse events in CLL patients treated with acalabrutinib in clinical practice in Russia [Up to 2 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥18 years
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Confirmed diagnosis of CLL
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Patient started treatment with monotherapy acalabrutinib (prescribed by physician decision no more than 4 weeks ago before screening)
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Capability of providing written Informed Consent Form
Exclusion Criteria:
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Patients not corresponded to inclusion criteria
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Pregnancy
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Lactation
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Patients included in open-label trials
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Previous Bruton tyrosine kinase inhibitors (BTKI) treatment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Irkutsk | Russian Federation | ||
| 2 | Research Site | Kalinigrad | Russian Federation | ||
| 3 | Research Site | Khabarovsk | Russian Federation | 680009 | |
| 4 | Research Site | Krasnoyarsk | Russian Federation | 660022 | |
| 5 | Research Site | Moscow | Russian Federation | 125284 | |
| 6 | Research Site | Moscow | Russian Federation | 129110 | |
| 7 | Research Site | Nizhniy Novgorod | Russian Federation | 603126 | |
| 8 | Research Site | Novosibirsk | Russian Federation | 630091 | |
| 9 | Research Site | Saint Petersburg | Russian Federation | 198205 | |
| 10 | Research Site | Saratov | Russian Federation | 410028 | |
| 11 | Research Site | Tomsk | Russian Federation | 634063 | |
| 12 | Research Site | Ufa | Russian Federation | 450054 | |
| 13 | Research Site | Yakutsk | Russian Federation | 677008 |
Sponsors and Collaborators
- AstraZeneca
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D8220R00021