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
1 other identifier
observational
250
1 country
19
Brief Summary
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..
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2023
Longer than P75 for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2023
CompletedStudy Start
First participant enrolled
December 13, 2023
CompletedFirst Posted
Study publicly available on registry
December 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2028
March 23, 2026
March 1, 2026
4.8 years
December 6, 2023
March 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
Reasons for treatment discontinuation
Once a year until end of the study ( 3 years from start of acalabrutinib)
effectiveness of acalabrutinib
Once a year until end of the study ( 3 years from start of acalabrutinib)
Baseline clinical and demographic characteristics
At first data collection for cohort 1 in December 2023 and at first data collection for cohort 2 in December 2024
acalabrutinib interruption
Once a year until end of the study (3 years from the start of acalabrutinib)
time to interruption
Once a year until end of the study ( 3 years from start of acalabrutinib)
- +4 more secondary outcomes
Study Arms (2)
Cohort 1
December 2023 - collecting data retrospectively from patients routinely initiated on acalabrutinib between January - December 2023
Cohort 2
December 2024-collecting data retrospectively from patients routinely initated on acalabrutinib between January - December 2024
Interventions
CLL patients routinely initiated on acalabrutinib by their physician between January 2023 -December 2024. Retrospective secondary data collection
Eligibility Criteria
CLL patients routinely initiated on acalabrutinib in front-line or subsequent treatment during the study eligibility window January 2023-December 2024
You may qualify if:
- 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
You may not qualify if:
- The treatment with acalabrutinib was initiated during an interventional clinical trial
- Enrolment performed less than 30 days from start of treatment with acalabrutinib
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (19)
Research Site
Piteşti, Argeş, 110084, Romania
Research Site
Oradea, Bihor County, 410469, Romania
Research Site
Cluj-Napoca, Cluj, 400015, Romania
Research Site
Craiova, Dolj, 200143, Romania
Research Site
Deva, Hunedoara County, 330084, Romania
Research Site
Baia Mare, Maramureş, 430031, Romania
Research Site
Târgu Mureş, Mureș County, 540136, Romania
Research Site
Piatra Neamţ, Neamț County, 610136, Romania
Research Site
Timișoara, Timiș County, 300239, Romania
Research Site
Timișoara, Timiș County, 300254, Romania
Research Site
Focşani, Vrancea, 620034, Romania
Research Site
Brasov, 500052, Romania
Research Site
Bucharest, 20125, Romania
Research Site
Bucharest, 22328, Romania
Research Site
Bucharest, 301710, Romania
Research Site
Bucharest, 30171, Romania
Research Site
Bucharest, 50098, Romania
Research Site
Galati, 800578, Romania
Research Site
Iași, 700483, Romania
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2023
First Posted
December 14, 2023
Study Start
December 13, 2023
Primary Completion (Estimated)
September 30, 2028
Study Completion (Estimated)
September 30, 2028
Last Updated
March 23, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- 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.
- 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.
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