Chronic Lymphocytic LeukemiaREACHNCT06170671
REAl-world Outcomes in CHronic Lymphocytic Leukemia Patients Receiving Acalabrutinib in Romania
An observational study of Chronic Lymphocytic Leukemia, run by AstraZeneca at 19 sites in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- Non interventional study
- How many people
- 250 participants
- Where
- 19 sitesRomania
- Study dates
- 13 Dec 2023to 30 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CLL patients routinely initiated on acalabrutinib in front-line or subsequent treatment during the study eligibility window January 2023-December 2024
Who may be able to join
- 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
Who cannot join
- The treatment with acalabrutinib was initiated during an interventional clinical trial
- Enrolment performed less than 30 days from start of treatment with acalabrutinib
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Romania19 sites
Research Site
Baia Mare, Maramureş, 430031
Research Site
Brasov, 500052
Research Site
Bucharest, 20125
Research Site
Bucharest, 22328
Research Site
Bucharest, 301710
Research Site
Bucharest, 30171
Research Site
Bucharest, 50098
Research Site
Cluj-Napoca, Cluj, 400015
Research Site
Craiova, Dolj, 200143
Research Site
Deva, Hunedoara County, 330084
Research Site
Focşani, Vrancea, 620034
Research Site
Galati, 800578
Research Site
Iași, 700483
Research Site
Oradea, Bihor County, 410469
Research Site
Piatra Neamţ, Neamț County, 610136
Research Site
Piteşti, Argeş, 110084
Research Site
Târgu Mureş, Mureș County, 540136
Research Site
Timișoara, Timiș County, 300239
Research Site
Timișoara, Timiș County, 300254
About this study
Official title: 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..
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- Non interventional study
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non interventional studyDrug
CLL patients routinely initiated on acalabrutinib by their physician between January 2023 -December 2024. Retrospective secondary data collection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | December 2023 - collecting data retrospectively from patients routinely initiated on acalabrutinib between January - December 2023 Receives: Drug: Non interventional study | |
| Cohort 2 | December 2024-collecting data retrospectively from patients routinely initated on acalabrutinib between January - December 2024 Receives: Drug: Non interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Once a year during the 3 years of follow up since acalabrutinib start
Secondary outcomes (9)
Reasons for treatment discontinuation
Reasons for acalabrutinib interruption
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: once a year until the end of the study ( 3 years from acalabrutinib start)
acalabrutinib dose changes
Percentage of patients with dose changes
Measured: 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)
Measured: 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.
Measured: once a year until end of the study( 3 years from acalabrutinib start)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start13 Dec 2023
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170671
- Sponsor's protocol ID
- D8220R00055
- Acronym
- REACH
- Status last verified
- Sep 2026
- First submitted
- 6 Dec 2023
- Last updated
- 23 Sep 2026
- Results posted
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Secondary Data Collection Study to Describe Acalabrutinib Treatment Outcomes in Chronic Lymphocytic Leukemia Patients in Real-life Setting in Romania
- ClinicalTrials.gov ID
- NCT06170671
- Acronym / sponsor ID
- REACH / D8220R00055
- Conditions
- Chronic Lymphocytic Leukemia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: Non interventional studyDecember 2023 - collecting data retrospectively from patients routinely initiated on acalabrutinib between January - December 2023 |
| Cohort 2 | – | Drug: Non interventional studyDecember 2024-collecting data retrospectively from patients routinely initated on acalabrutinib between January - December 2024 |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CLL patients routinely initiated on acalabrutinib in front-line or subsequent treatment during the study eligibility window January 2023-December 2024
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- The treatment with acalabrutinib was initiated during an interventional clinical trial
- Enrolment performed less than 30 days from start of treatment with acalabrutinib
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non interventional studyCLL patients routinely initiated on acalabrutinib by their physician between January 2023 -December 2024. Retrospective secondary data collection | Drug | Cohort 1, Cohort 2 |
Primary outcome
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
9 secondary outcomes
Reasons for treatment discontinuation
Time frame: 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)
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
acalabrutinib interruption
Time frame: 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)
duration of interruption
Time frame: 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)
Reasons of acalabrutinib dose changes
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphocytic Leukemia, run by AstraZeneca at 19 sites in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to acalabrutinib treatment discontinuation (TTD) (time frame: Once a year during the 3 years of follow up since acalabrutinib start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.