REAl-world Outcomes in CHronic Lymphocytic Leukemia Patients Receiving Acalabrutinib in Romania

Chronic Lymphocytic Leukemia Clinical Trial

— REACH  

Official title:

Observational, Secondary Data Collection Study to Describe Acalabrutinib Treatment Outcomes in Chronic Lymphocytic Leukemia Patients in Real-life Setting in Romania

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06170671
• Other study ID #: D8220R00055
• Status: Recruiting
• Start date: December 13, 2023
• Est. completion date: September 30, 2028

Study information

• Verified date: June 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Acalabrutinib received European Medicines Agency approval on November 2020 for for CLL adult patients, either as monotherapy or in combination with obinutuzumab, in previously untreated patients or as monotherapy in patients who have received at least one prior therapy and is reimbursed in Romania since January 2023. In the absence of disease registries or national datasets patient population receiving acalabrutinib in real life setting is not well characterized. The study aims to look into this population outcomes and clinical characteristics having as primary objective time to discontinuation by line of treatment and secondary objectives: reasons for discontinuation, effectiveness of acalabrutinib in real-life practice, baseline clinical and demographic characteristics, treatment patterns and major determinants of treatment discontinuation. The study will retrospectively collect longitudinal data from 250 patients at national level,at pre-defined timepoints for 3 years, from 2 sequential cohorts,1st one enrolled on December 2023 and 2nd one enrolled in December 2024 based on the acalabrutinib start year..

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: September 30, 2028
• Est. primary completion date: September 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

Inclusion Criteria:

• Adult patients (age >18 years) with confirmed diagnosis of chronic lymphocytic leukemia/ small lymphocytic lymphoma

• Patients initiating front-line or subsequent treatment with acalabrutinib between January 2023 and Dec 2024 according to the national therapeutic protocol

• Patients able and willing to provide their written informed consent to participate in the study

Exclusion Criteria:

• The treatment with acalabrutinib was initiated during an interventional clinical trial

• Enrolment performed less than 30 days from start of treatment with acalabrutinib

Related Conditions & MeSH terms

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

Intervention

Drug:
• Non interventional study
CLL patients routinely initiated on acalabrutinib by their physician between January 2023 -December 2024. Retrospective secondary data collection

Locations

Country	Name	City	State
Romania	Research Site	Baia Mare	Maramures
Romania	Research Site	Brasov
Romania	Research Site	Bucuresti
Romania	Research Site	Bucuresti
Romania	Research Site	Bucuresti
Romania	Research Site	Bucuresti
Romania	Research Site	Cluj Napoca	Cluj
Romania	Research Site	Craiova	Dolj
Romania	Research Site	Deva	Hunedoara
Romania	Research Site	Iasi
Romania	Research Site	Oradea	Bihor
Romania	Research Site	Targu Mures	Mures
Romania	Research Site	Timisoara	Timis
Romania	Research Site	Timisoara	Timis

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to acalabrutinib treatment discontinuation (TTD)	TTD is defined as the time between the first day of acalabrutinib treatment and the day that acalabrutinib is definitely stopped for whatever reason or death	Once a year during the 3 years of follow up since acalabrutinib start
Secondary	Reasons for treatment discontinuation	Reasons for acalabrutinib interruption	Once a year until end of the study ( 3 years from start of acalabrutinib)
Secondary	effectiveness of acalabrutinib	Real world progression free survival (rwPFS) is defined as the time from initiation of acalabrutinib therapy (index date) until earliest record of disease progression determined by physicians' assessment (clinical or radiological progression or start of a new line therapy),or death	Once a year until end of the study ( 3 years from start of acalabrutinib)
Secondary	Baseline clinical and demographic characteristics	Demographic characteristics (age,gender, BMI) and disease characteristics (age at diagnosis, staging, symptoms, active disease criteria,previous treatment	At first data collection for cohort 1 in December 2023 and at first data collection for cohort 2 in December 2024
Secondary	acalabrutinib interruption	Percentage of patients with acalabrutinib interruption	Once a year until end of the study (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 the study ( 3 years from start of acalabrutinib)
Secondary	duration of interruption	Time between the first day of acalabrutinib interruption and the first day of acalabrutinib restart	once a year until the end of the study ( 3 years from acalabrutinib start)
Secondary	acalabrutinib dose changes	Percentage of patients with dose changes	once a year until the end of the study ( 3 years from acalabrutinib start)
Secondary	Reasons of acalabrutinib dose changes	Reasons of acalabrutinib dose changes (all including adverse events)	once a year until the end of the study ( 3 years from acalabrutinib start)
Secondary	Major determinant of treatment discontinuation	a multivariate analysis (Cox model) will be performed to study correlation between TTD and patient characteristics at baseline.	once a year until end of the study( 3 years from acalabrutinib start)