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

iOMEDICO

Status: Active, not recruiting

Conditions: CLL

Treatments: Drug: Calquence

Study type: Observational

Funder types: Industry

Identifiers

NCT05517265

IOM-100473

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

45 participants in 2 patient groups

first-line therapy

Description:

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

Treatment:

Drug: Calquence

Drug: Calquence

later-line therapy

Description:

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

Treatment:

Drug: Calquence

Drug: Calquence