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

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: Chronic Lymphocytic Leukemia
• Intervention / Treatment: Drug: Non interventional study

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

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

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

How is the study designed?

Number of groups / cohorts

2

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)	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	Reasons for acalabrutinib interruption	Once a year until end of the study ( 3 years from start of acalabrutinib)
effectiveness 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	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	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 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 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	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	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	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

• Sponsor: AstraZeneca

Study record dates

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: Pathologic Processes; Neoplasms; Chronic Disease; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Leukemia, Lymphocytic, Chronic, B-Cell
• 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.