CompletedNot Applicable

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

Germany45 participantsStarted 2022-10-12

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Incidence proportion of patients with major bleeding event according to Schulman et al.

Timeframe: Baseline until end of acalabrutinib treatment (+ 30 days safety follow-up); up to 41 months

Trial details

NCT IDNCT05517265

SponsoriOMEDICO AG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-03-20

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