REAl-world Outcomes in CHronic Lymphocytic Leukemia Patients Receiving Acalabrutinib in Romania (REACH)

June 17, 2026 updated by: AstraZeneca

Observational, Secondary Data Collection Study to Describe Acalabrutinib Treatment Outcomes in Chronic Lymphocytic Leukemia Patients in Real-life Setting in Romania

Acalabrutinib received European Medicines Agency approval on November 2020 for for CLL adult patients, either as monotherapy or in combination with obinutuzumab, in previously untreated patients or as monotherapy in patients who have received at least one prior therapy and is reimbursed in Romania since January 2023. In the absence of disease registries or national datasets patient population receiving acalabrutinib in real life setting is not well characterized. The study aims to look into this population outcomes and clinical characteristics having as primary objective time to discontinuation by line of treatment and secondary objectives: reasons for discontinuation, effectiveness of acalabrutinib in real-life practice, baseline clinical and demographic characteristics, treatment patterns and major determinants of treatment discontinuation. The study will retrospectively collect longitudinal data from 250 patients at national level,at pre-defined timepoints for 3 years, from 2 sequential cohorts,1st one enrolled on December 2023 and 2nd one enrolled in December 2024 based on the acalabrutinib start year..

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

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

Study Locations

  • Romania
      • Brasov, Romania, 500052
        • Research Site
      • Bucharest, Romania, 22328
        • Research Site
      • Bucharest, Romania, 50098
        • Research Site
      • Bucharest, Romania, 20125
        • Research Site
      • Bucharest, Romania, 301710
        • Research Site
      • Bucharest, Romania, 30171
        • Research Site
      • Galati, Romania, 800578
        • Research Site
      • Iași, Romania, 700483
        • Research Site
    • Argeş
      • Piteşti, Argeş, Romania, 110084
        • Research Site
    • Bihor County
      • Oradea, Bihor County, Romania, 410469
        • Research Site
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400015
        • Research Site
    • Dolj
      • Craiova, Dolj, Romania, 200143
        • Research Site
    • Hunedoara County
      • Deva, Hunedoara County, Romania, 330084
        • Research Site
    • Maramureş
      • Baia Mare, Maramureş, Romania, 430031
        • Research Site
    • Mureș County
      • Târgu Mureş, Mureș County, Romania, 540136
        • Research Site
    • Neamț County
      • Piatra Neamţ, Neamț County, Romania, 610136
        • Research Site
    • Timiș County
      • Timișoara, Timiș County, Romania, 300239
        • Research Site
      • Timișoara, Timiș County, Romania, 300254
        • Research Site
    • Vrancea
      • Focşani, Vrancea, Romania, 620034
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

CLL patients routinely initiated on acalabrutinib in front-line or subsequent treatment during the study eligibility window January 2023-December 2024

Description

Inclusion Criteria:

  • Adult patients (age >18 years) with confirmed diagnosis of chronic lymphocytic leukemia/ small lymphocytic lymphoma
  • Patients initiating front-line or subsequent treatment with acalabrutinib between January 2023 and Dec 2024 according to the national therapeutic protocol
  • Patients able and willing to provide their written informed consent to participate in the study

Exclusion Criteria:

  • The treatment with acalabrutinib was initiated during an interventional clinical trial
  • Enrolment performed less than 30 days from start of treatment with acalabrutinib

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1
December 2023 - collecting data retrospectively from patients routinely initiated on acalabrutinib between January - December 2023
Drug: Non interventional study
CLL patients routinely initiated on acalabrutinib by their physician between January 2023 -December 2024. Retrospective secondary data collection
Cohort 2
December 2024-collecting data retrospectively from patients routinely initated on acalabrutinib between January - December 2024
Drug: Non interventional study
CLL patients routinely initiated on acalabrutinib by their physician between January 2023 -December 2024. Retrospective secondary data collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to acalabrutinib treatment discontinuation (TTD)
Time Frame: Once a year during the 3 years of follow up since acalabrutinib start
TTD is defined as the time between the first day of acalabrutinib treatment and the day that acalabrutinib is definitely stopped for whatever reason or death
Once a year during the 3 years of follow up since acalabrutinib start

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reasons for treatment discontinuation
Time Frame: Once a year until end of the study ( 3 years from start of acalabrutinib)
Reasons for acalabrutinib interruption
Once a year until end of the study ( 3 years from start of acalabrutinib)
effectiveness of acalabrutinib
Time Frame: Once a year until end of the study ( 3 years from start of acalabrutinib)
Real world progression free survival (rwPFS) is defined as the time from initiation of acalabrutinib therapy (index date) until earliest record of disease progression determined by physicians' assessment (clinical or radiological progression or start of a new line therapy),or death
Once a year until end of the study ( 3 years from start of acalabrutinib)
Baseline clinical and demographic characteristics
Time Frame: At first data collection for cohort 1 in December 2023 and at first data collection for cohort 2 in December 2024
Demographic characteristics (age,gender, BMI) and disease characteristics (age at diagnosis, staging, symptoms, active disease criteria,previous treatment
At first data collection for cohort 1 in December 2023 and at first data collection for cohort 2 in December 2024
acalabrutinib interruption
Time Frame: Once a year until end of the study (3 years from the start of acalabrutinib)
Percentage of patients with acalabrutinib interruption
Once a year until end of the study (3 years from the start of acalabrutinib)
time to interruption
Time Frame: Once a year until end of the study ( 3 years from start of acalabrutinib)
Time between first day of acalabrutinib and the day of first interruption of acalabrutinib
Once a year until end of the study ( 3 years from start of acalabrutinib)
duration of interruption
Time Frame: once a year until the end of the study ( 3 years from acalabrutinib start)
Time between the first day of acalabrutinib interruption and the first day of acalabrutinib restart
once a year until the end of the study ( 3 years from acalabrutinib start)
acalabrutinib dose changes
Time Frame: once a year until the end of the study ( 3 years from acalabrutinib start)
Percentage of patients with dose changes
once a year until the end of the study ( 3 years from acalabrutinib start)
Reasons of acalabrutinib dose changes
Time Frame: once a year until the end of the study ( 3 years from acalabrutinib start)
Reasons of acalabrutinib dose changes (all including adverse events)
once a year until the end of the study ( 3 years from acalabrutinib start)
Major determinant of treatment discontinuation
Time Frame: once a year until end of the study( 3 years from acalabrutinib start)
a multivariate analysis (Cox model) will be performed to study correlation between TTD and patient characteristics at baseline.
once a year until end of the study( 3 years from acalabrutinib start)

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)

December 13, 2023

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

September 30, 2028

Study Registration Dates

First Submitted

December 6, 2023

First Submitted That Met QC Criteria

December 6, 2023

First Posted (Actual)

December 14, 2023

Study Record Updates

Last Update Posted (Actual)

June 18, 2026

Last Update Submitted That Met QC Criteria

June 17, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D8220R00055

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 Vivli.org. All requests 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 approved.

Supporting

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer 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 anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

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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