ALICIA (Acalabrutinib in CLL Therapy)

Chronic Lymphocytic Leukemia Clinical Trial

— ALICIA  

Official title:

ALICIA (Observational Prospective Study of Acalabrutinib in CLL Therapy in Real Clinical Practice in Russia)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04746950
• Other study ID #: D8220R00021
• Status: Recruiting
• Start date: February 3, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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:

• 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Age =18 years

• Confirmed diagnosis of CLL

• Patient started treatment with monotherapy acalabrutinib (prescribed by physician decision no more than 4 weeks ago before screening)

• Capability of providing written Informed Consent Form

Exclusion Criteria:

• Patients not corresponded to inclusion criteria

• Pregnancy

• Lactation

• Patients included in open-label trials

• Previous Bruton tyrosine kinase inhibitors (BTKI) treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Locations

Country	Name	City	State
Russian Federation	Research Site	Irkutsk
Russian Federation	Research Site	Kalinigrad
Russian Federation	Research Site	Khabarovsk
Russian Federation	Research Site	Krasnoyarsk
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Nizhniy Novgorod
Russian Federation	Research Site	Novosibirsk
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Saratov
Russian Federation	Research Site	Tomsk
Russian Federation	Research Site	Ufa
Russian Federation	Research Site	Yakutsk

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• progression-free survival (rwPFS) in patients with CLL who are treated with acalabrutinib in clinical practice in Russia		Up to 2 years
Primary	• incidence of adverse events and serious adverse events in CLL patients treated with acalabrutinib in clinical practice in Russia		Up to 2 years