National Acalabrutinib Observational Study

Chronic Lymphocytic Leukemia Clinical Trial

— NAOS  

Official title:

A French Multicentric Observational Study of Acalabrutinib in the Treatment of Chronic Lymphocytic Leukemia Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05437250
• Other study ID #: D8220R00045
• Status: Active, not recruiting
• Start date: September 13, 2022
• Est. completion date: November 15, 2026

Study information

• Verified date: February 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• 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.

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

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)