Chronic Lymphocytic LeukemiaNAOSNCT05437250
National Acalabrutinib Observational Study
An observational study of Chronic Lymphocytic Leukemia, run by AstraZeneca at 61 sites in France.
Trial summary
The efficacy and safety of acalabrutinib in the treatment of patients with chronic lymphocytic leukemia (CLL) have been well established through 3 phase III clinical trials (ELEVATE TN, ASCEND, ELEVATE R/R) that led to European Medicines Agency approval in November 2020. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- Non interventional study
- How many people
- 350 participants
- Where
- 61 sitesFrance
- Study dates
- 13 Sep 2022to 15 Nov 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CLL patients
Who may be able to join
- Male or female patients aged ≥ 18 years old,
- CLL patients initiated with acalabrutinib at their physician's discretion between January 1st 2021 and December 31st 2022,
- Patients alive at study initiation and who have been informed verbally and/or in writing about this study, and who do not object to their data being electronically processed or subjected to data quality control (certified by physician); or patient who died before study initiation and who did not object to data collection for research purpose(s) during his or her lifetime.
Who cannot join
- Patients participating in a clinical trial with an investigational drug within 30 days prior to acalabrutinib initiation,
- Patients who initiated acalabrutinib treatment before January 1st 2021.
Trial locations and contacts
61 sites in 1 country.
61 sites in 1 country
France61 sites
Research Site
Aix-en-Provence
Research Site
Amiens
Research Site
Angers
Research Site
Ars-Laquenexy
Research Site
Avignon
Research Site
Besançon
Research Site
Béziers
Research Site
Bobigny
Research Site
Bourg-en-Bresse
Research Site
Brest
Research Site
Caen
Research Site
Cahors
Research Site
Carcassonne
Research Site
Cesson-Sévigné
Research Site
Chalon-sur-Saône
Research Site
Chambéry
Research Site
Clamart
Research Site
Clermont-Ferrand
Research Site
Corbeil-Essonnes
Research Site
Dunkirk
Research Site
Essey-lès-Nancy
Research Site
Grenoble
Research Site
La Chaussée-Saint-Victor
Research Site
La Tronche
Research Site
LE Chesnay-rocquencourt
Research Site
Le Kremlin-Bicêtre
Research Site
Le Mans
Research Site
Le Puy-en-Velay
Research Site
Lens
Research Site
Libourne
Research Site
Lille
Research Site
Limoges
Research Site
Lorient
Research Site
Marseille
Research Site
Meaux
Research Site
Melun
Research Site
Mont-de-Marsan
Research Site
Nantes
Research Site
Nevers
Research Site
Nîmes
Research Site
Orléans
Research Site
Paris
Research Site
Périgueux
Research Site
Perpignan
Research Site
Pessac
Research Site
Pontoise
Research Site
Reims
Research Site
Rennes
Research Site
Roubaix
Research Site
Rouen
Research Site
Saumur
Research Site
Tarbes
Research Site
Toulouse
Research Site
Tours
Research Site
Trévenans
Research Site
Troyes
Research Site
Valence
Research Site
Vandœuvre-lès-Nancy
Research Site
Vantoux
Research Site
Vesoul
Research Site
Vichy
About this study
Official title: A French Multicentric Observational Study of Acalabrutinib in the Treatment of Chronic Lymphocytic Leukemia Patients
The efficacy and safety of acalabrutinib in the treatment of patients with chronic lymphocytic leukemia (CLL) have been well established through 3 phase III clinical trials (ELEVATE TN, ASCEND, ELEVATE R/R) that led to European Medicines Agency approval in November 2020. The aim of this French longitudinal, non-interventional/observational, multicenter study is to describe the efficacy and safety of acalabrutinib treatment for CLL patients in real life.
The primary objective is then to estimate the time to discontinuation of acalabrutinib therapy and the reasons for discontinuation, overall and by treatment line.
Read more
The secondary objectives are to describe the baseline clinical and demographic characteristics of patients with CLL treated with acalabrutinib, to assess the efficacy of acalabrutinib through progression-free survival, overall survival, time to next treatment or death, describe acalabrutinib treatment patterns in CLL patients and reasons, identify key determinants of acalabrutinib discontinuation in CLL patients, estimate healthcare resource utilization. The overall response rate will be estimated as an exploratory objective.
Patients included in this study will be CLL patients treated with acalabrutinib at the discretion of their physician between January 1, 2021 and December 31, 2022, who have been informed of the study and do not object to electronic processing of their data for research purposes (or do not object during their lifetime in the event of the patient's death prior to study initiation).
Secondary data will be extracted from the hospital's patient records once a year. The protocol calls for the recruitment of 350 patients at 70 centres with a 3-year follow-up. Interim analyses will be performed annually until the end of the study.
- 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 initiated with acalabrutinib at their physician's discretion between January 1, 2021 and December 31, 2022 . Secondary data collection
| Study group | Role | What they receive |
|---|---|---|
| CLL patients treated with acalabrutinib at their physician's discretion | In each center, all patients meeting the inclusion criteria and no exclusion criteria will be offered to participate in this study. Receives: Drug: Non interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Discontinuation
Time between first day of acalabrutinib and the day that acalabrutinib is stopped
Measured: Up to 3 years from the start of acalabrutinib
Secondary outcomes (12)
Baseline clinical and demographic characteristics in CLL patients
Demographic characteristics (gender, age BMI) and disease characteristics (age at diagnosis, previous treatment, staging, prognosis criteria, constitutive symptoms)
Measured: First interim analysis (year1) and second interim analysis (year2)
Effectiveness of acalabrutinib
Real World Progression Free Survival Overall Survival Time to next treatment or Death
Measured: Once a year until end of study (up to 3 years from the start of acalabrutinib)
Major determinants of treatment discontinuation
Multivariate analysis to study correlation between Time to Discontinuation and patient characteristics at baseline
Measured: Once a year until end of study (up to 3 years from the start of acalabrutinib)
Acalabrutinib interruption
Percentage of patients with acalabrutinib interruption
Measured: Once a year until end of study (up to 3 years from the start of acalabrutinib)
Reasons of acalabrutinib interruption
Reasons of acalabrutinib interruption
Measured: Once a year until end of study (up to 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 study (up to 3 years from the start of acalabrutinib)
Duration interruption
Time between first day of acalabrutinib interruption and the day of acalabrutinib restart
Measured: Once a year until end of study (up to 3 years from the start of acalabrutinib)
Acalabrutinib dose changes
Percentage of patients with acalabrutinib dose changes
Measured: Once a year until end of study (up to 3 years from the start of acalabrutinib)
Reasons of Acalabrutinib dose changes
Reasons of acalabrutinib dose changes
Measured: Once a year until end of study (up to 3 years from the start of acalabrutinib)
Healthcare Resources Utilization : Hospitalization
Number of day of hospitalization
Measured: Once a year until end of study (up to 3 years from the start of acalabrutinib)
Healthcare Resources Utilization : Accident and Emergency Visits
Number of Accident and Emergency Visits
Measured: Once a year until end of study (up to 3 years from the start of acalabrutinib)
Healthcare Resources Utilization : Outpatient Visits
Number of Outpatient Visits
Measured: Once a year until end of study (up to 3 years from the start of acalabrutinib)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start13 Sep 2022
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Nov 2026 (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
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anne Quinquennel, Doctor, Study director, Hôpital Robert Debré, Reims, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437250
- Sponsor's protocol ID
- D8220R00045
- Acronym
- NAOS
- Status last verified
- Aug 2026
- First submitted
- 8 Jun 2022
- Last updated
- 26 Aug 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A French Multicentric Observational Study of Acalabrutinib in the Treatment of Chronic Lymphocytic Leukemia Patients
- ClinicalTrials.gov ID
- NCT05437250
- Acronym / sponsor ID
- NAOS / D8220R00045
- Conditions
- Chronic Lymphocytic Leukemia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 29 Jun 2022 (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.
The efficacy and safety of acalabrutinib in the treatment of patients with chronic lymphocytic leukemia (CLL) have been well established through 3 phase III clinical trials (ELEVATE TN, ASCEND, ELEVATE R/R) that led to European Medicines Agency approval in November 2020. The aim of this French longitudinal, non-interventional/observational, multicenter study is to describe the efficacy and safety of acalabrutinib treatment for CLL patients in real life.
The primary objective is then to estimate the time to discontinuation of acalabrutinib therapy and the reasons for discontinuation, overall and by treatment line.
The secondary objectives are to describe the baseline clinical and demographic characteristics of patients with CLL treated with acalabrutinib, to assess the efficacy of acalabrutinib through progression-free survival, overall survival, time to next treatment or death, describe acalabrutinib treatment patterns in CLL patients and reasons, identify key determinants of acalabrutinib discontinuation in CLL patients, estimate healthcare resource utilization. The overall response rate will be estimated as an exploratory objective.
Patients included in this study will be CLL patients treated with acalabrutinib at the discretion of their physician between January 1, 2021 and December 31, 2022, who have been informed of the study and do not object to electronic processing of their data for research purposes (or do not object during their lifetime in the event of the patient's death prior to study initiation).
Secondary data will be extracted from the hospital's patient records once a year. The protocol calls for the recruitment of 350 patients at 70 centres with a 3-year follow-up. Interim analyses will be performed annually until the end of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CLL patients treated with acalabrutinib at their physician's discretion | – | Drug: Non interventional studyIn each center, all patients meeting the inclusion criteria and no exclusion criteria will be offered to participate in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CLL patients
Key inclusion criteria (3 listed)
- Male or female patients aged ≥ 18 years old,
- CLL patients initiated with acalabrutinib at their physician's discretion between January 1st 2021 and December 31st 2022,
- Patients alive at study initiation and who have been informed verbally and/or in writing about this study, and who do not object to their data being electronically processed or subjected to data quality control (certified by physician); or patient who died before study initiation and who did not object to data collection for research purpose(s) during his or her lifetime.
Key exclusion criteria (2 listed)
- Patients participating in a clinical trial with an investigational drug within 30 days prior to acalabrutinib initiation,
- Patients who initiated acalabrutinib treatment before January 1st 2021.
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 initiated with acalabrutinib at their physician's discretion between January 1, 2021 and December 31, 2022 . Secondary data collection | Drug | CLL patients treated with acalabrutinib at their physician's discretion |
Primary outcome
Time to Discontinuation
Time frame: Up to 3 years from the start of acalabrutinib
Time between first day of acalabrutinib and the day that acalabrutinib is stopped
12 secondary outcomes
Baseline clinical and demographic characteristics in CLL patients
Time frame: First interim analysis (year1) and second interim analysis (year2)
Effectiveness of acalabrutinib
Time frame: Once a year until end of study (up to 3 years from the start of acalabrutinib)
Major determinants of treatment discontinuation
Time frame: Once a year until end of study (up to 3 years from the start of acalabrutinib)
Acalabrutinib interruption
Time frame: Once a year until end of study (up to 3 years from the start of acalabrutinib)
Reasons of acalabrutinib interruption
Time frame: Once a year until end of study (up to 3 years from the start of acalabrutinib)
Time to interruption
Time frame: Once a year until end of study (up to 3 years from the start of acalabrutinib)
Duration interruption
Time frame: Once a year until end of study (up to 3 years from the start of acalabrutinib)
Acalabrutinib dose changes
Time frame: Once a year until end of study (up to 3 years from the start of acalabrutinib)
Reasons of Acalabrutinib dose changes
Time frame: Once a year until end of study (up to 3 years from the start of acalabrutinib)
Healthcare Resources Utilization : Hospitalization
Time frame: Once a year until end of study (up to 3 years from the start of acalabrutinib)
Healthcare Resources Utilization : Accident and Emergency Visits
Time frame: Once a year until end of study (up to 3 years from the start of acalabrutinib)
Healthcare Resources Utilization : Outpatient Visits
Time frame: Once a year until end of study (up to 3 years from the start of acalabrutinib)
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 26 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Lymphocytic Leukemia
Active, not recruitingObservational study
Clinical, Laboratory and Epidemiologic Characterization of Individuals and Families at High Risk of Hematologic Cancer
Waldenstrom Macroglobulinemia, Chronic Lymphocytic Leukemia
RecruitingObservational study
Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment
Hairy Cell Leukemia (HCL), Chronic Lymphocytic Leukemia (CLL)
RecruitingObservational study
Cancer Experience Registry (CER) for Cancer Patients and Caregivers
Neoplasms, Cancer
Active, not recruitingPhase 1/2
Study to Evaluate the Safety and Preliminary Efficacy of Ibrutinib and Pembrolizumab in Patients With Chronic Lymphocytic Leukemia (CLL) or Mantle Cell Lymphoma (MCL)
Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma
Active, not recruitingPhase 1
Copanlisib and Nivolumab in Treating Patients With Richter's Transformation or Transformed Indolent Non-Hodgkin Lymphoma
Chronic Lymphocytic Leukemia, Diffuse Large B-Cell Lymphoma
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.
Anne Quinquennel, Doctor study director
Hôpital Robert Debré, Reims, France
61 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 61 sites in France.
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 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in France. 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 Discontinuation (time frame: Up to 3 years from the start of acalabrutinib). 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 26 Aug 2026; AzTrials last refreshed its copy on 30 Oct 2026.