An observational study in Chronic Lymphocytic Leukemia, sponsored by AstraZeneca. Recruiting at 4 sites in Belarus. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by AstraZeneca · Observational
to address critical gap in knowledge, providing essential data on the real-world effectiveness, safety, associated with acalabrutinib treatment in patients with CLL
This observational, prospective, multi-center study aims to gather real-world data (RWD) on acalabrutinib's use in routine clinical practice for CLL treatment in Belarus. Patients will be monitored without intervention, and all treatment decisions will be at the clinician's discretion. The study duration per patient will be approximately two years, with periodic data collection at regular intervals, ensuring comprehensive assessment of treatment effectiveness, patient safety, and quality of life metrics.
2,036 studies on the registry are indexed under Leukemia, Lymphocytic, Chronic, B-Cell; 237 are open to participants now.
This study's planned enrollment of 50 is below the median of 146 across 215 observational studies indexed under Leukemia, Lymphocytic, Chronic, B-Cell.
Browse Leukemia, Lymphocytic, Chronic, B-Cell studies →AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
no control group or comparator involved
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 months
Reasons for treatment discontinuation
Collected from source medical documents (e.g., progression, toxicity, patient preference, physician's decision).
Time frame: up to 25 months
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 months
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 months
Subsequent treatments
qualitative categorical descriptions of therapies following acalabrutinib discontinuation
Time frame: up to 25 months
Treatment interruptions
temporary discontinuation of acalabrutinib lasting ≥7 days but \<30 days, with documented intent to resume treatment. Interruptions and their documented reasons will be captured from medical records
Time frame: up to 25 months
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 months
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 months
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting information: Informed consent form, Clinical study report
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Dec 2029, 48 months after the start.
Of 34 industry-sponsored observational studies under Leukemia, Lymphocytic, Chronic, B-Cell, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 66. This study's planned 48 months is below that.
Counting every sponsor, half of 104 studies reached it within 60 months; a quarter within 32 and three quarters within 176.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Leukemia, Lymphocytic, Chronic, B-Cell →