Non-interventional study evaluating the response to treatment in patients with chronic lymphocytic leukaemia (CLL) depending on rituximab-chemotherapy regimen

Abstract

A multicenter, prospective, observational, non-interventional study evaluated the response to treatment in patients with chronic lymphocytic leukemia (CLL) depending on the rituximab-chemotherapy (R-chemo) regimen used in routine clinical practice in Poland. The primary endpoint was the overall response rate (ORR) regarding the R-chemo regimen. The secondary endpoints were complete remission (CR), partial remission (PR), progressive disease (PD) and stable disease (SD) rates. A total of 400 CLL patients were enrolled in 20 sites in Poland. Data were collected on-line using eCRF during 6-months rituximab treatment. There were 150 treatment-naive patients (37.5%) and 250 patients with recurrent disease (62.5%) enrolled to the study. The overall ORR in R-FC-treated patients was 87.28%, 78.57% for the R-COP regimen, and for other regimens – 51.72%. Complete remission was achieved in 141 patients (36.25%), including 16.40% in patients receiving first-line treatment and 11.76% in relapsed disease. Partial remission was achieved in 166 patients (42.67%), including 38.4% in patients on first-line treatment and 38.56% in patients treated for recurrence. Complete or partial responses were achieved in 78.92% in total. No new safety signals were detected in comparison to safety profile described in Summary of Product Characteristics.