NCT05517265Completed
Acalabrutinib in Patients With Chronic Lymphocytic Leukemia With Direct Oral Anticoagulation (CICERO)
A Non-interventional, Prospective, Open-label, Observational Study Evaluating the Effectiveness and Safety of Acalabrutinib (Calquence®) in Patients With Chronic Lymphocytic Leukemia (CLL) Receiving Direct Oral Anticoagulation (DOAC).
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 45 (actual)
- First submitted
- 19 Aug 2022
- Start date
- 12 Oct 2022
- Primary completion date
- 20 Mar 2026
- Lead sponsor
- iOMEDICO AG
- Diseases
- Chronic lymphocytic leukaemia
- NCT number
- NCT05517265
What you commit to
- Study type: Observational
- Participants enrolled: 45
- From 12 Oct 2022 to the primary completion date, 20 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Combination of acalabrutinib with other substances than obinutuzumab for CLL treatment
- Participation in an interventional clinical trial with acalabrutinib
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Prof. Dr. Fenchel & Dr. Winkler MVZ Träger GbR Coordinator of this site? Confirm its status | Saalfeld | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.