Lymphoma Clinical Trial
Official title:
Open Study in Phase II to Evaluate Efficacy of Initial R-CHOP Combination in Folicular Lymphoma no Treated Previously. Consolidation w Ith One Dose of 90Y Ibritumomab Tiuxetan (Zevalin®) Versus Maintenance Treatment With Rituximab (MabThera®)
After conventional induction treatment with R-CHOP (Rituximab, cyclophosphamide, adriamycin,
vincristine and prednisone) the patients are randomized to:
A: Consolidation with one dose of 90Y Ibritumomab tiuxetan (Zevalin®) 0,4 mCi/Kg
B: Maintenance with 375 mg/m2 of Rituximab every 8 weeks during 24 months
The study will evaluate the benefit of consolidation treatment with 90Y Ibritumomab tiuxetan
(Zevalin®) or maintenance with rituximab (MabThera®) in terms of progression free survival,
after induction with chemotherapy and rituximab in folicular lymphoma patients no treated
previously.
The other aims are, evaluate the global survival, event free survival, time until next
treatment, response rate after consolidation or maintenance treatment, quality of life,
security of two branches and relation cost-efectivity
;
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