Clinical trial NCT04746950: ALICIA (Acalabrutinib in CLL Therapy)
Official title: ALICIA (Observational Prospective Study of Acalabrutinib in CLL Therapy in Real Clinical Practice in Russia)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Lymphocytic Leukemia
Keywords: chronic lymphocytic leukemia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2021-02-10
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The Enrolled set will be represented by eligible patients who have signed an informed consent form to participate in the study.

It is estimated that approximately 200 patients will be enrolled in the study. Study population will consist of adult patients with diagnosed CLL ≥ 18 years old (treatment naïve (TN) or relapsed/refractory (R/R)) for whom acalabrutinib in monotherapy was prescribed by treating physician decision no more than 4 weeks ago before screening.

Brief summary: This is a multicenter non-interventional observational study conducted with a single hand arm to collect real-world data. In this study, commercially available acalabrutinib will be used as prescribed treatment for CLL as per the treating physician's best clinical judgement. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice.

A multi-center collaborative effort in 15 centers selected from regions within Russia will help capture more patients into the database, rather than limiting the data to a single institution. This will be critical for:

* increasing database sample size
* reducing bias (single institution bias)
* increasing result's generalizability to the whole Russian population Being an observational study, only data available from routine clinical practice and standard of care (SoC), in line with national and international laws and regulations, will be recorded.

Patients will be treated according to prescribing information, with visit frequency and assessments performed according to routine medical practice and SoC. Only data corresponding to these visits and assessments will be collected as part of the study.

Data for the study will be transcribed and entered into an electronic Case Report Form (eCRF) from the patient's medical records. The site investigator will be responsible for ensuring that all required data is collected and entered into the eCRF with the involvement of clinical research organization


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Confirmed diagnosis of CLL
* Patient started treatment with monotherapy acalabrutinib (prescribed by physician decision no more than 4 weeks ago before screening)
* Capability of providing written Informed Consent Form

Exclusion Criteria:

* Patients not corresponded to inclusion criteria
* Pregnancy
* Lactation
* Patients included in open-label trials
* Previous Bruton tyrosine kinase inhibitors (BTKI) treatment

Primary outcomes:
measure: • progression-free survival (rwPFS) in patients with CLL who are treated with acalabrutinib in clinical practice in Russia
timeFrame: Up to 2 years
measure: • incidence of adverse events and serious adverse events in CLL patients treated with acalabrutinib in clinical practice in Russia
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ufa
country: Russian Federation
facility: Research Site
state: Bashkortostan Republic
city: Kaliningrad
country: Russian Federation
facility: Research Site
state: Kaliningrad Region
city: Khabarovsk
country: Russian Federation
facility: Research Site
state: Khabarovsk Region
city: Syktyvkar
country: Russian Federation
facility: Research Site
state: Komi Republic
city: Krasnoyarsk
country: Russian Federation
facility: Research Site
state: Krasnoyarsk Region
city: Saint Petersburg
country: Russian Federation
facility: Research Site
state: Leningrad Region
city: Moscow
country: Russian Federation
facility: Research Site
state: Moscow Region
city: Moscow
country: Russian Federation
facility: Research Site
state: Moscow Region
city: Nizhny Novgorod
country: Russian Federation
facility: Research Site
state: Nizhny Novgorod Region
city: Novosibirsk
country: Russian Federation
facility: Research Site
state: Novosibirsk Region
city: Yakutsk
country: Russian Federation
facility: Research Site
state: Sakha Republic
city: Saratov
country: Russian Federation
facility: Research Site
state: Saratov Region
Study officials:
References: