National Acalabrutinib Observational Study
NAOS
A French Multicentric Observational Study of Acalabrutinib in the Treatment of Chronic Lymphocytic Leukemia Patients
1 other identifier
observational
350
1 country
61
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2022
Longer than P75 for all trials
61 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
June 8, 2022
CompletedFirst Posted
Study publicly available on registry
June 29, 2022
CompletedStudy Start
First participant enrolled
September 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 15, 2026
March 2, 2026
February 1, 2026
4.2 years
June 8, 2022
February 27, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Time to Discontinuation
Time between first day of acalabrutinib and the day that acalabrutinib is stopped
Up to 3 years from the start of acalabrutinib
Secondary Outcomes (12)
Baseline clinical and demographic characteristics in CLL patients
First interim analysis (year1) and second interim analysis (year2)
Effectiveness of acalabrutinib
Once a year until end of study (up to 3 years from the start of acalabrutinib)
Major determinants of treatment discontinuation
Once a year until end of study (up to 3 years from the start of acalabrutinib)
Acalabrutinib interruption
Once a year until end of study (up to 3 years from the start of acalabrutinib)
Reasons of acalabrutinib interruption
Once a year until end of study (up to 3 years from the start of acalabrutinib)
- +7 more secondary outcomes
Other Outcomes (1)
Overall Response Rate
Once a year until end of study (up to 3 years from the start of acalabrutinib)
Study Arms (1)
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.
Interventions
CLL patients initiated with acalabrutinib at their physician's discretion between January 1, 2021 and December 31, 2022 . Secondary data collection
Eligibility Criteria
CLL patients
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (61)
Research Site
Aix-en-Provence, France
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Amiens, France
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Angers, France
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Ars-Laquenexy, France
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Avignon, France
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Besançon, France
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Béziers, France
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Bobigny, France
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Bourg-en-Bresse, France
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Brest, France
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Caen, France
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Cahors, France
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Carcassonne, France
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Cesson-Sévigné, France
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Chalon-sur-Saône, France
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Chambéry, France
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Clamart, France
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Clermont-Ferrand, France
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Corbeil-Essonnes, France
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Dunkirk, France
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Essey-lès-Nancy, France
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Grenoble, France
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La Chaussée-Saint-Victor, France
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La Tronche, France
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LE Chesnay-rocquencourt, France
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Le Kremlin-Bicêtre, France
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Le Mans, France
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Le Puy-en-Velay, France
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Lens, France
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Libourne, France
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Lille, France
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Limoges, France
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Lorient, France
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Marseille, France
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Meaux, France
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Melun, France
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Mont-de-Marsan, France
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Nantes, France
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Nevers, France
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Nîmes, France
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Orléans, France
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Paris, France
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Perpignan, France
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Pessac, France
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Périgueux, France
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Pontoise, France
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Reims, France
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Rennes, France
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Roubaix, France
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Rouen, France
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Saumur, France
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Tarbes, France
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Toulouse, France
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Tours, France
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Trévenans, France
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Troyes, France
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Valence, France
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Vandœuvre-lès-Nancy, France
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Vantoux, France
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Vesoul, France
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Vichy, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Anne Quinquennel, Doctor
Hôpital Robert Debré, Reims, France
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2022
First Posted
June 29, 2022
Study Start
September 13, 2022
Primary Completion (Estimated)
November 15, 2026
Study Completion (Estimated)
November 15, 2026
Last Updated
March 2, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share