Trial Information

The Efficacy and Safety of Combined Treatment With Fresh Frozen Plasma and Rituximab (Mabthera) in Patients With Advanced Refractory Chronic Lymphocytic Leukemia. Single-arm Phase II Study. Analysis of Complement Activation Pathways.

Indolent B cell Non-Hodgkin's lymphoma patients show good responses to Rituximab,
administered either alone or preferably with standard chemotherapy. The response to
Rituximab of patients with CLL is inferior in comparison to other indolent B cell
malignancies. The therapeutic approach of combining treatments with Rituximab and fresh
frozen plasma (FFP) used by us first in one case and following the impressive response - in
additional 2 patients, was undertaken on the basis of two observations.

We assumed, that the addition of FFP to Rituximab treatment would increase and/or restore
the efficacy of Rituximab in advanced CLL patients that are resistant to therapy by
correcting their abnormal complement system thus allowing improved complement activation and
increase anti-leukemic activity.

The major aims of the study are: (1) To establish the efficacy of the combination of FFP and
RTX as determined by response rate. (2) To elucidate the effector mechanism responsible for
the efficacy of the FFP-Rituximab combination. The secondary aims of the study are (1) To
establish the response duration of the combination of FFP and RTX as determined by time to
progression. and time to re treatment (2) To determine the safety of the combined treatment.

The study is designed as a single-arm, phase II study evaluating the efficacy and safety of
combined treatment with FFP and RTX in advanced refractory chronic lymphocytic leukemia,
along with an analysis of the complement system associated parameters.