Rituximab-2cda and Prolongation of Therapy With Rituximab Alone in Chronic Lymphocytic Leukaemia and Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukaemia (CLL) is a lymphoproliferative disorder characterized by the
progressive accumulation of monoclonal peripheral B cells in bone marrow, peripheral blood
and lymphoid tissues. Median survival is about 10 years. It is now clear that front line
therapy for a patient with CLL requiring treatment should be the association of purine
analogue and rituximab with or without cyclophosphamide. Concerning the choice of the purine
analogue, similar results have been obtained by using cladribine instead of fludarabine.
Although cladribine is less commonly used, the direct comparison between the two analogues
for what concerns efficacy and toxicity, has confirmed the same profile of the two drugs.
Encouraging results have been obtained using the monoclonal antibody in association with the
The utilization of rituximab as a maintenance therapy could improve the response in cases of
persistence of minimal residual disease as well as delay the insurgence of relapses thus
increasing the DFS.
The objective of this study is to confirm the efficacy of the association of R-2cda and of
evaluating the efficacy of prolongation of therapy with additional infusions of Rituximab
alone in increasing and prolonging the duration of the response. The results of this study
will be compared with existing clinical results from a group of 42 pts already treated as
standard with R-2cda without additional rituximab infusions.
Patients enrolled in the study will receive 4 cycles of R-2-CdA therapy. Patients, who
achieve a partial response or complete response after the therapy with R- 2-CdA, will
prolong therapy with Rituximab. The therapy will begin 3 months after the end of the
induction therapy and patients will receive one administration every 2 months for a total of
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response to treatment
response will be evaluated according to Hallek criteria and definitions
at month 17
Giovanni Martinelli, MD
European Institute of Oncology
Italy: The Italian Medicines Agency