Acalabrutinib in Patients With Chronic Lymphocytic Leukemia With Direct Oral Anticoagulation (CICERO)

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

ACTIVE_NOT_RECRUITING

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-12

Study Completion Date

2026-03-31

Brief Summary

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The goal of CICERO is to investigate the clinical outcome with a particular focus on prospective data on safety using acalabrutinib (+/- obinutuzumab) in CLL patients receiving co-medication with DOACs (edoxaban, rivaroxaban, dabigatran, apixaban) irrespective of treatment line.

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Detailed Description

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The non-interventional study (NIS) CICERO will collect real-world data to explore acalabrutinib (+/- obinutuzumab) in adult CLL patients (irrespective of treatment line) who receive co-medication with DOACs. The primary focus of the study is to investigate the incidence proportion of bleeding events. Due to the mostly elderly CLL patient population, CLL patients often suffer from multiple cardiovascular comorbidities including atrial fibrillation (AF), deep vein thrombosis (DVT) or pulmonary embolism (PE) which make anticoagulation mandatory.

Up to now, no systematic and prospective evaluation on interactions of BTKis and DOACs has been conducted.

In Order to assess bleeding events, a questionnaire will be used to document if bleeding events occurred in-between visits in routine care. Patients will be asked at each visit if distinct events occurred in the time between the last visit until the current visit and discuss the questionnaire with the physician to determine of any (S)AE occurred until end of acalabrutinib treatment.

Conditions

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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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first-line therapy

Patients enrolled for first-line acalabrutinib (+/- obinutuzumab).

Calquence

Intervention Type DRUG

acalabrutinib (+/- obinutuzumab) according to Calquence® SmPC.

later-line therapy

Pre-treated patients enrolled for later-line acalabrutinib therapy.

Calquence

Intervention Type DRUG

acalabrutinib according to Calquence® SmPC.

Interventions

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Calquence

acalabrutinib (+/- obinutuzumab) according to Calquence® SmPC.

Intervention Type DRUG

Calquence

acalabrutinib according to Calquence® SmPC.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* Patients with chronic lymphocytic leukemia (CLL) and decision for treatment with acalabrutinib (+/- obinutuzumab) according to current SmPC as assessed by the treating physician or already started treatment with acalabrutinib (+/- obinutuzumab) according to current SmPC no longer than 6 weeks ago
* Other concomitant disease resulting in medical need of or already under treatment with direct oral anticoagulant (DOAC) treatment with edoxaban (Lixiana®) or rivaroxaban (Xarelto®) or dabigatran (Pradaxa®) or apixaban (Eliquis®) according to the respective current SmPC.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Signed, written informed consent.

Exclusion Criteria

* Combination of acalabrutinib with other substances than obinutuzumab for CLL treatment
* Participation in an interventional clinical trial with acalabrutinib

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No