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

NCT05517265 | Completed

• 1 other identifier: IOM-100473
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

CLL

Keywords

CLL; Acalabrutinib (+/- Obinutuzumab); DOAC

Outcome Measures

Primary Outcomes (1)

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

  Bleeding event is defined as major according to Schulmann et al., if it is fatal (contributes to death) and/or symptomatic in a critical area or organ (such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome) and/or causing a decrease in hemoglobin of 2 g/dL (1.24 mmol/l) or more or requires a transfusion of 2 or more units of whole blood or red blood cells. Incidence proportion (cumulative incidence) is calculated as the number of patients with bleeding event while on treatment (+30 days safety follow-up), divided by the number of patients in the full analysis population.

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

Secondary Outcomes (26)

• Incidence proportion of clinically relevant non-major (CRNM) bleeding events

  Baseline, up to 41 months

• Major (according to Schulman et al.) and/or CRNM bleeding events.

  Baseline, up to 41 months

• Any bleeding event.

  Baseline, up to 41 months

• Incidence proportion of major bleeding according to Ghia et al.

  Baseline, up to 41 months

• Time to first Occurrence of major bleeding events

  Baseline, up to 41 months

Study Arms (2)

first-line therapy

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

Drug: Calquence

later-line therapy

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

Drug: Calquence

Interventions

Calquence DRUG

acalabrutinib (+/- obinutuzumab) according to Calquence® SmPC.

first-line therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with CLL receiving acalabrutinib (+/- obinutuzumab) and co-medication with DOAC.

You may qualify if:

• 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.

You may not qualify if:

• Combination of acalabrutinib with other substances than obinutuzumab for CLL treatment
• Participation in an interventional clinical trial with acalabrutinib

Sponsors & Collaborators

• iOMEDICO AG: lead
• AstraZeneca: collaborator

Study Sites (1)

Prof. Dr. Fenchel & Dr. Winkler MVZ Träger GbR

Saalfeld, Thuringia, 07318, Germany

Location

Related Publications (2)

• Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005 Apr;3(4):692-4. doi: 10.1111/j.1538-7836.2005.01204.x.

  PMID: 15842354 BACKGROUND

• Ghia P, Pluta A, Wach M, Lysak D, Kozak T, Simkovic M, Kaplan P, Kraychok I, Illes A, de la Serna J, Dolan S, Campbell P, Musuraca G, Jacob A, Avery E, Lee JH, Liang W, Patel P, Quah C, Jurczak W. ASCEND: Phase III, Randomized Trial of Acalabrutinib Versus Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia. J Clin Oncol. 2020 Sep 1;38(25):2849-2861. doi: 10.1200/JCO.19.03355. Epub 2020 May 27.

  PMID: 32459600 BACKGROUND

MeSH Terms

Interventions

acalabrutinib

Study Officials

• Klaus Fenchel, Prof. Dr.

  Onkologische Praxisklinik Hämatologie/ Onkologie und Gerinnungsstörungen

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: August 26, 2022
• Study Start: October 12, 2022
• Primary Completion: March 20, 2026
• Study Completion: March 20, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)