Clinical trial NCT05437250: National Acalabrutinib Observational Study
Official title: A French Multicentric Observational Study of Acalabrutinib in the Treatment of Chronic Lymphocytic Leukemia Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Lymphocytic Leukemia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2022-06-29
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CLL patients

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Time to Discontinuation
timeFrame: Up to 3 years from the start of acalabrutinib
Secondary outcomes:
measure: Baseline clinical and demographic characteristics in CLL patients
timeFrame: First interim analysis (year1) and second interim analysis (year2)
measure: Effectiveness of acalabrutinib
timeFrame: Once a year until end of study (up to 3 years from the start of acalabrutinib)
measure: Major determinants of treatment discontinuation
timeFrame: Once a year until end of study (up to 3 years from the start of acalabrutinib)
measure: Acalabrutinib interruption
timeFrame: Once a year until end of study (up to 3 years from the start of acalabrutinib)
measure: Reasons of acalabrutinib interruption
timeFrame: Once a year until end of study (up to 3 years from the start of acalabrutinib)
measure: Time to interruption
timeFrame: Once a year until end of study (up to 3 years from the start of acalabrutinib)
measure: Duration interruption
timeFrame: Once a year until end of study (up to 3 years from the start of acalabrutinib)
measure: Acalabrutinib dose changes
timeFrame: Once a year until end of study (up to 3 years from the start of acalabrutinib)
measure: Reasons of Acalabrutinib dose changes
timeFrame: Once a year until end of study (up to 3 years from the start of acalabrutinib)
measure: Healthcare Resources Utilization : Hospitalization
timeFrame: Once a year until end of study (up to 3 years from the start of acalabrutinib)
measure: Healthcare Resources Utilization : Accident and Emergency Visits
timeFrame: Once a year until end of study (up to 3 years from the start of acalabrutinib)
measure: Healthcare Resources Utilization : Outpatient Visits
timeFrame: Once a year until end of study (up to 3 years from the start of acalabrutinib)
Other outcomes:
measure: Overall Response Rate
timeFrame: Once a year until end of study (up to 3 years from the start of acalabrutinib)
Locations:
city: Aix-en-provence
country: France
facility: Research Site
city: Amiens
country: France
facility: Research Site
city: Angers Cedex 9
country: France
facility: Research Site
city: Ars-laquenexy
country: France
facility: Research Site
city: Avignon
country: France
facility: Research Site
city: Besancon
country: France
facility: Research Site
city: Beziers
country: France
facility: Research Site
city: Bobigny
country: France
facility: Research Site
city: Bourg en Bresse
country: France
facility: Research Site
city: Brest
country: France
facility: Research Site
city: Caen
country: France
facility: Research Site
city: Cahors
country: France
facility: Research Site
city: Carcassonne
country: France
facility: Research Site
city: Cesson-Sevigne
country: France
facility: Research Site
city: Chalon Sur Saone
country: France
facility: Research Site
city: Chambery
country: France
facility: Research Site
city: Clamart
country: France
facility: Research Site
city: Clermont Ferrand
country: France
facility: Research Site
city: Corbeil-essonnes
country: France
facility: Research Site
city: Dunkerque Cedex 1
country: France
facility: Research Site
city: Essey-les-nancy
country: France
facility: Research Site
city: Grenoble
country: France
facility: Research Site
city: La Chaussee-saint-victor
country: France
facility: Research Site
city: La Tronche
country: France
facility: Research Site
city: LE Chesnay-rocquencourt
country: France
facility: Research Site
city: Le Kremlin-bicetre
country: France
facility: Research Site
city: Le Mans
country: France
facility: Research Site
city: Le Puy-en-Velay
country: France
facility: Research Site
city: Lens
country: France
facility: Research Site
city: Libourne
country: France
facility: Research Site
city: Lille
country: France
facility: Research Site
city: Limoges Cedex
country: France
facility: Research Site
city: Lorient
country: France
facility: Research Site
city: Marseille
country: France
facility: Research Site
city: Meaux Cedex
country: France
facility: Research Site
city: Melun
country: France
facility: Research Site
city: Mont-de-marsan
country: France
facility: Research Site
city: Nantes
country: France
facility: Research Site
city: Nevers
country: France
facility: Research Site
city: Nimes
country: France
facility: Research Site
city: Orleans
country: France
facility: Research Site
city: Paris Cedex 12
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Perigueux
country: France
facility: Research Site
city: Perpignan
country: France
facility: Research Site
city: Pessac
country: France
facility: Research Site
city: Pontoise
country: France
facility: Research Site
city: Reims
country: France
facility: Research Site
city: Rennes Cedex 09
country: France
facility: Research Site
city: Roubaix
country: France
facility: Research Site
city: Rouen
country: France
facility: Research Site
city: Saumur
country: France
facility: Research Site
city: Tarbes
country: France
facility: Research Site
city: Toulouse
country: France
facility: Research Site
city: Tours Cedex 9
country: France
facility: Research Site
city: Trevenans
country: France
facility: Research Site
city: Troyes
country: France
facility: Research Site
city: Valence
country: France
facility: Research Site
city: Vandoeuvre Les Nancy
country: France
facility: Research Site
city: Vantoux
country: France
facility: Research Site
city: Vesoul
country: France
facility: Research Site
city: Vichy
country: France
facility: Research Site
Study officials:
affiliation: Hôpital Robert Debré, Reims, France
name: Anne Quinquennel, Doctor
role: STUDY_DIRECTOR
References: