ALICIA (Acalabrutinib in CLL Therapy) (ALICIA)

March 20, 2024 updated by: AstraZeneca

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

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Russian Federation
      • Irkutsk, Russian Federation
        • Withdrawn
        • Research Site
      • Kalinigrad, Russian Federation
        • Recruiting
        • Research Site
      • Khabarovsk, Russian Federation, 680009
        • Recruiting
        • Research Site
      • Krasnoyarsk, Russian Federation, 660022
        • Recruiting
        • Research Site
      • Moscow, Russian Federation, 125284
        • Not yet recruiting
        • Research Site
      • Moscow, Russian Federation, 129110
        • Recruiting
        • Research Site
      • Nizhniy Novgorod, Russian Federation, 603126
        • Not yet recruiting
        • Research Site
      • Novosibirsk, Russian Federation, 630091
        • Recruiting
        • Research Site
      • Saint Petersburg, Russian Federation, 198205
        • Active, not recruiting
        • Research Site
      • Saratov, Russian Federation, 410028
        • Recruiting
        • Research Site
      • Tomsk, Russian Federation, 634063
        • Not yet recruiting
        • Research Site
      • Ufa, Russian Federation, 450054
        • Recruiting
        • Research Site
      • Yakutsk, Russian Federation, 677008
        • Recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
• progression-free survival (rwPFS) in patients with CLL who are treated with acalabrutinib in clinical practice in Russia
Time Frame: Up to 2 years
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
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2021

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

December 23, 2020

First Submitted That Met QC Criteria

February 9, 2021

First Posted (Actual)

February 10, 2021

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D8220R00021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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