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Trial Title:
Acalabrutinib in Patients With Chronic Lymphocytic Leukemia With Direct Oral Anticoagulation (CICERO)
NCT ID:
NCT05517265
Condition:
CLL
Conditions: Official terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Acalabrutinib
Conditions: Keywords:
CLL
Acalabrutinib (+/- Obinutuzumab)
DOAC
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Calquence
Description:
acalabrutinib (+/- obinutuzumab) according to Calquence® SmPC.
Arm group label:
first-line therapy
Intervention type:
Drug
Intervention name:
Calquence
Description:
acalabrutinib according to Calquence® SmPC.
Arm group label:
later-line therapy
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.
Detailed 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.
Criteria for eligibility:
Study pop:
Adult patients with CLL receiving acalabrutinib (+/- obinutuzumab) and co-medication with
DOAC.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Prof. Dr. Fenchel & Dr. Winkler MVZ Träger GbR
Address:
City:
Saalfeld
Zip:
07318
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Klaus Fenchel, Prof. Dr.
Start date:
October 12, 2022
Completion date:
October 12, 2025
Lead sponsor:
Agency:
iOMEDICO AG
Agency class:
Industry
Collaborator:
Agency:
AstraZeneca
Agency class:
Industry
Source:
iOMEDICO AG
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05517265
