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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05437250
Other study ID # D8220R00045
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 13, 2022
Est. completion date November 15, 2026

Study information

Verified date May 2024
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 350
Est. completion date November 15, 2026
Est. primary completion date November 15, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Non interventional study
CLL patients initiated with acalabrutinib at their physician's discretion between January 1, 2021 and December 31, 2022 . Secondary data collection

Locations

Country Name City State
France Research Site Aix-en-provence
France Research Site Amiens
France Research Site Angers Cedex 9
France Research Site Ars-laquenexy
France Research Site Avignon
France Research Site Besancon
France Research Site Beziers
France Research Site Bobigny
France Research Site Bourg en Bresse
France Research Site Brest
France Research Site Caen
France Research Site Cahors
France Research Site Carcassonne
France Research Site Cesson-Sevigne
France Research Site Chalon Sur Saone
France Research Site Chambery
France Research Site Clamart
France Research Site Clermont Ferrand
France Research Site Corbeil-essonnes
France Research Site Dunkerque Cedex 1
France Research Site Essey-les-nancy
France Research Site Grenoble
France Research Site La Chaussee-saint-victor
France Research Site La Tronche
France Research Site LE Chesnay-rocquencourt
France Research Site Le Kremlin-bicetre
France Research Site Le Mans
France Research Site Le Puy-en-Velay
France Research Site Lens
France Research Site Libourne
France Research Site Lille
France Research Site Limoges Cedex
France Research Site Lorient
France Research Site Marseille
France Research Site Meaux Cedex
France Research Site Melun
France Research Site Mont-de-marsan
France Research Site Nantes
France Research Site Nevers
France Research Site Nimes
France Research Site Orleans
France Research Site Paris
France Research Site Paris Cedex 12
France Research Site Perigueux
France Research Site Perpignan
France Research Site Pessac
France Research Site Pontoise
France Research Site Reims
France Research Site Rennes Cedex 09
France Research Site Roubaix
France Research Site Rouen
France Research Site Saumur
France Research Site Tarbes
France Research Site Toulouse
France Research Site Tours Cedex 9
France Research Site Trevenans
France Research Site Troyes
France Research Site Valence
France Research Site Vandoeuvre Les Nancy
France Research Site Vantoux
France Research Site Vesoul
France Research Site Vichy

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other Overall Response Rate Response to treatment assessed by investigator Once a year until end of study (up to 3 years from the start of acalabrutinib)
Primary 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 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) First interim analysis (year1) and second interim analysis (year2)
Secondary Effectiveness of acalabrutinib Real World Progression Free Survival Overall Survival Time to next treatment or Death Once a year until end of study (up to 3 years from the start of acalabrutinib)
Secondary Major determinants of treatment discontinuation Multivariate analysis to study correlation between Time to Discontinuation and patient characteristics at baseline Once a year until end of study (up to 3 years from the start of acalabrutinib)
Secondary Acalabrutinib interruption Percentage of patients with acalabrutinib interruption Once a year until end of study (up to 3 years from the start of acalabrutinib)
Secondary Reasons of acalabrutinib interruption Reasons of acalabrutinib interruption Once a year until end of study (up to 3 years from the start of acalabrutinib)
Secondary Time to interruption Time between first day of acalabrutinib and the day of first interruption of acalabrutinib Once a year until end of study (up to 3 years from the start of acalabrutinib)
Secondary Duration interruption Time between first day of acalabrutinib interruption and the day of acalabrutinib restart Once a year until end of study (up to 3 years from the start of acalabrutinib)
Secondary Acalabrutinib dose changes Percentage of patients with acalabrutinib dose changes Once a year until end of study (up to 3 years from the start of acalabrutinib)
Secondary Reasons of Acalabrutinib dose changes Reasons of acalabrutinib dose changes Once a year until end of study (up to 3 years from the start of acalabrutinib)
Secondary Healthcare Resources Utilization : Hospitalization Number of day of hospitalization Once a year until end of study (up to 3 years from the start of acalabrutinib)
Secondary Healthcare Resources Utilization : Accident and Emergency Visits Number of Accident and Emergency Visits Once a year until end of study (up to 3 years from the start of acalabrutinib)
Secondary Healthcare Resources Utilization : Outpatient Visits Number of Outpatient Visits Once a year until end of study (up to 3 years from the start of acalabrutinib)
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