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Clinical Trials/NCT04746950
NCT04746950CompletedNot Applicable

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

AstraZeneca14 sites in 1 country90 target enrollmentStarted: February 3, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
90
Locations
14
Primary Endpoint
• progression-free survival (rwPFS) in patients with CLL who are treated with acalabrutinib in clinical practice in Russia

Study Overview

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

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

• progression-free survival (rwPFS) in patients with CLL who are treated with acalabrutinib in clinical practice in Russia

Time Frame: Up to 2 years

• incidence of adverse events and serious adverse events in CLL patients treated with acalabrutinib in clinical practice in Russia

Time Frame: Up to 2 years

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (14)

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