ALICIA (Acalabrutinib in CLL Therapy)
ALICIA
ALICIA (Observational Prospective Study of Acalabrutinib in CLL Therapy in Real Clinical Practice in Russia)
1 other identifier
observational
90
1 country
15
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:
- 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2021
Longer than P75 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2020
CompletedStudy Start
First participant enrolled
February 3, 2021
CompletedFirst Posted
Study publicly available on registry
February 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2026
CompletedJuly 17, 2026
July 1, 2026
5.1 years
December 23, 2020
July 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
• 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
The Enrolled set will be represented by eligible patients who have signed an informed consent form to participate in the study. It is estimated that approximately 200 patients will be enrolled in the study. Study population will consist of adult patients with diagnosed CLL ≥ 18 years old (treatment naïve (TN) or relapsed/refractory (R/R)) for whom acalabrutinib in monotherapy was prescribed by treating physician decision no more than 4 weeks ago before screening.
You may qualify if:
- 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
You may not qualify if:
- Pregnancy
- Lactation
- Patients included in open-label trials
- Previous Bruton tyrosine kinase inhibitors (BTKI) treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (15)
Research Site
Ufa, Bashkortostan Republic, 450054, Russia
Research Site
Kaliningrad, Kaliningrad Oblast, Russia
Research Site
Khabarovsk, Khabarovskiy Kray, 680009, Russia
Research Site
Syktyvkar, Komi, Russia
Research Site
Krasnoyarsk, Krasnoyarsk Region, 660022, Russia
Research Site
Saint Petersburg, Leningradskaya Oblast', 198205, Russia
Research Site
Moscow, Moscow Oblast, 125284, Russia
Research Site
Moscow, Moscow Oblast, 129110, Russia
Research Site
Nizhny Novgorod, Nizhny Novgorod Oblast, Russia
Research Site
Novosibirsk, Novosibirsk Oblast, 630091, Russia
Research Site
Yakutsk, Sakha Republic, 677008, Russia
Research Site
Saratov, Saratov Oblast, 410028, Russia
Research Site
Kaliningrad, Russia
Research Site
Nizhny Novgorod, Russia
Research Site
Tomsk, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2020
First Posted
February 10, 2021
Study Start
February 3, 2021
Primary Completion
February 28, 2026
Study Completion
February 28, 2026
Last Updated
July 17, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.