Spots Global Cancer Trial Database for ZAR2007: R-CHOP in Folicular Lymphoma Patients no Treated Previously. Consolidation With 90Y Ibritumomab Tiuxetan (Zevalin®) Versus Maintenance Treatment With Rituximab (MabThera®)
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Trial Identification
Brief Title: ZAR2007: R-CHOP in Folicular Lymphoma Patients no Treated Previously. Consolidation With 90Y Ibritumomab Tiuxetan (Zevalin®) Versus Maintenance Treatment With Rituximab (MabThera®)
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®)
Study ID: NCT00662948
Conditions
Study Description
Brief Summary: 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
Detailed Description: 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
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Hospital de Alcorcón, Alcorcón, , Spain
Hospital germans Trias i Pujol, Badalona, , Spain
Hospital Clínic, Barcelona, , Spain
Hospital de la santa Creu i Sant Pau, Barcelona, , Spain
Hospital del Mar, Barcelona, , Spain
Hospital Juan Canalejo, La Coruña, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Hospital Doce de Octubre, Madrid, , Spain
Hospital La Paz, Madrid, , Spain
Hospital Ramón y Cajal, Madrid, , Spain
MD Anderson, Madrid, , Spain
Hospital Virgen de la Arrixaca, Murcia, , Spain
Hospital son Dureta, Palma de Mallorca, , Spain
Hospital Clínico, Salamanca, , Spain
Hospital de Donostia, San Sebastián, , Spain
Hoaspital Marqués de Valdecilla, Santander, , Spain
Hospital Clínico Universitario, Santiago de Compostela, , Spain
Hospital General, V Alencia, , Spain
Hospital Clínico, Valencia, , Spain
Hospital Dr Pesset, Valencia, , Spain
Hospital La Fe, Valencia, , Spain
Contact Details
Name: Canales Miguel, Dr
Affiliation: Hospital La Paz
Role: STUDY_CHAIR
Name: Lopez-Guillermo Armando, Dr
Affiliation: Hospital Clinic of Barcelona
Role: STUDY_CHAIR
Name: Tomas Jose Francisco, Dr
Affiliation: MD Anderson- Madrid
Role: STUDY_CHAIR
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