Observ Prosp Study of Acalabrutinib in CLL Therapy in Real Clinical Practice in Belarus
ConditionChronic Lymphocytic Leukemia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAstraZeneca
About this trial
to address critical gap in knowledge, providing essential data on the real-world effectiveness, safety, associated with acalabrutinib treatment in patients with CLL
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
Confirmed diagnosis of CLL.
Newly prescribed acalabrutinib monotherapy within the previous four weeks preceding study enrolment. Monotherapy is defined as acalabrutinib prescribes without concomitant administration (or planned initiation) of other anti-leukemic agents (e.g. obinutuzumab, venetoclax, bendamustine) within ± 30 days of acalabrutinib initiation.
Treatment-naïve or R/R CLL.
Disqualifiers
Patients not satisfying any of the inclusion criteria.
Prior treatment with any BTK inhibitor.
Participation in other ongoing clinical trials.
Pregnant or breastfeeding females
Trial population
The study population comprises adult patients (≥18 years old) diagnosed with CLL, who have been newly prescribed acalabrutinib monotherapy within four weeks prior to study enrolment. This includes both treatment-naïve patients and patients with relapsed/refractory (R/R) CLL.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
50 Participants
are grouped into 1 trial groupGroup A: patients with CLL
Trial outcomes
Primary outcomes
1
Time to treatment discontinuation
defined as the duration (in days) from the initiation of acalabrutinib therapy until the earliest of: 1. documented permanent treatment discontinuation as recorded in the patient's medical chart, or 2. death from any cause
Time frame
up to 25 monthsSecondary outcomes
1
Reasons for treatment discontinuation
Collected from source medical documents (e.g., progression, toxicity, patient preference, physician's decision).
Time frame
up to 25 months2
Rates for dose modifications
numerical count of dose reductions or holds, and categorization of underlying reasons (e.g., toxicity, drug interactions, comorbidities), derived from medical records
Time frame
up to 25 months3
reasons for dose modifications
numerical count of dose reductions or holds, and categorization of underlying reasons (e.g., toxicity, drug interactions, comorbidities), derived from medical records
Time frame
up to 25 months4
Subsequent treatments
qualitative categorical descriptions of therapies following acalabrutinib discontinuation
Time frame
up to 25 monthsOther outcomes
1
PFS measures, including one- and two-year rates
PFS, defined as the time from first dose to documented progression or death, assessed by Investigator based on clinical evaluations and diagnostic imaging, when available.
Time frame
up to 25 months2
OS rates
OS rates at one and two years of follow-up defined as proportion of alive participants at the given timepoint
Time frame
up to 25 monthsSponsors and contacts
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Source ClinicalTrials.gov