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

CompletedN/A

Sponsor: iOMEDICO AG

Conditions: CLL

Interventions: Calquence, Calquence

Countries: Germany

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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

Locations (1)

Saalfeld, Thuringia, Germany