Observ Prosp Study of Acalabrutinib in CLL Therapy in Real Clinical Practice in Belarus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-31

Study Completion Date

2029-12-31

Brief Summary

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to address critical gap in knowledge, providing essential data on the real-world effectiveness, safety, associated with acalabrutinib treatment in patients with CLL

Detailed Description

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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.

Conditions

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Chronic Lymphocytic Leukemia

Keywords

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CLL

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients with CLL

no control group or comparator involved

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.
* Ability and willingness to provide informed consent for study participation.

* Prior treatment with any BTK inhibitor.
* Participation in other ongoing clinical trials.
* Pregnant or breastfeeding females

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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AstraZeneca Clinical Study Information Center

Role: CONTACT

Phone: 1-877-240-9479

Email: [email protected]

Other Identifiers

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D8220R00090

Identifier Type: -

Identifier Source: org_study_id