Non Hodgkin Lymphoma Clinical Trial
Official title:
Prospective Non-randomized Multicenter Study to Assess the Efficacy Response Duration and Toxicity of RFC as First-line Treatment and R as Maintenance Treatment, in Patients Diagnosed of Follicular Non Hodgkin Lymphoma
The purpose of this study is to determine whether the rituximab administration with fludarabine and cyclophosphamide results, are better, than the ones obtained with conventional therapy such as CHOP (cyclophosphamide, adriamycin, vincristine, prednisone) and also to determine whether the rituximab administration as maintenance treatment during two years, increase the global clinical responses and the disease free time interval.
The use of monoclonal antibodies, specifically the chimerical humanized anti-CD20 monoclonal
antibody (Rituximab, MabThera®) represents one of the most innovative aspects in the
indolent lymphoma treatment. Preliminary data show from 40% to 50% of response with a median
response duration between 6 and 11 months in patients with relapsing FL. This response rate
increase when rituximab is administered as initial treatment.
Therefore, not only due to the clinical results but also to the tolerance, and based on an
innovative mechanism of action and in its minimal toxicity, it seems reasonable to raise the
possibility to incorporate the administration of the monoclonal antibody with
chemotherapeutic agents.
The development of a new treatment scheme that includes Rituximab administration within
treatment protocols that combine fludarabine and cyclophosphamide, whose results are better
than the ones obtained with conventional treatments such as CHOP, should increase the
molecular response rate and contribute therefore to increase the disease-free time interval
(time to progression), without adding any toxicity, in addition to achieve a higher
proportion of clinical responses (as global as complete responses). In order to increase the
time interval to progression, a maintenance treatment will be carried out for 2 years, which
has shown an evident benefit in the time to progression in preliminary studies.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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