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

Arms (2)

1. label

   first-line therapy

   description

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

   interventionNames

   1. Drug: Calquence

2. label

   later-line therapy

   description

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

   interventionNames

   1. Drug: Calquence

Primary outcomes (1)

1. measure

   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

   description

   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.