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Sponsors and Collaborators: |
PETHEMA Foundation GELCAB GLIMCE Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea GRUPO ARAGONÉS |
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Information provided by: | PETHEMA Foundation |
ClinicalTrials.gov Identifier: | NCT00662948 |
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
Condition | Intervention | Phase |
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Lymphoma |
Drug: Rituximab Drug: Ibritumomab tiuxetan |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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®) |
Estimated Enrollment: | 140 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | December 2016 |
Estimated Primary Completion Date: | May 2016 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Consolidation with one dose of 90Y Ibritumomab tiuxetan (Zevalin®) 0,4 mCi/Kg
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Drug: Ibritumomab tiuxetan
One dose of 90Y Ibritumomab tiuxetan, 0,4 mCi/Kg
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B: Active Comparator
Maintenance with 375 mg/m2 of Rituximab every 8 weeks during 24 months
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Drug: Rituximab
375 mg/m2 every 8 weeks during 24 months
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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
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Symptoms or signes wich indicate necesary treatment (GELF criteria):
Exclusion Criteria:
Criteria investigador:
Contact: Canales Miguel, Dr | 93 227 54 00 | |
Contact: Lopez-Guillermo Armando, Dr | 93 227 54 00 |
Spain | |
MD Anderson | |
Madrid, Spain | |
Hospital La Paz | |
Madrid, Spain | |
Hospital Clinico San Carlos | |
Madrid, Spain | |
Hospital Ramón y Cajal | |
Madrid, Spain | |
Hospital de Alcorcón | |
Alcorcón, Spain | |
Hospital Doce de Octubre | |
Madrid, Spain | |
Hospital Clínic | |
Barcelona, Spain | |
Hospital de la santa Creu i Sant Pau | |
Barcelona, Spain | |
Hospital germans Trias i Pujol | |
Badalona, Spain | |
Hospital del Mar | |
Barcelona, Spain | |
Hospital La Fe | |
Valencia, Spain | |
Hospital Clínico | |
Valencia, Spain | |
Hospital General | |
V alencia, Spain | |
Hoaspital Marqués de Valdecilla | |
Santander, Spain | |
Hospital Juan Canalejo | |
La Coruña, Spain | |
Hospital Clínico Universitario | |
Santiago de Compostela, Spain | |
Hospital Dr Pesset | |
Valencia, Spain | |
Hospital Clínico | |
Salamanca, Spain | |
Hospital de Donostia | |
San Sebastián, Spain | |
Hospital Virgen de la Arrixaca | |
Murcia, Spain | |
Hospital son Dureta | |
Palma de Mallorca, Spain |
Study Chair: | Canales Miguel, Dr | Hospital La Paz |
Study Chair: | Lopez-Guillermo Armando, Dr | Hospital Clinic Barcelona |
Study Chair: | Tomas Jose Francisco, Dr | MD Anderson- Madrid |
Responsible Party: | Pethema ( Pethema ) |
Study ID Numbers: | ZAR2007 |
Study First Received: | April 8, 2008 |
Last Updated: | April 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00662948 |
Health Authority: | Spain: Ministry of Health |
Folicular Lymphoma Consolidation Maintenance |
Antibodies, Monoclonal Lymphatic Diseases Antibodies Immunoproliferative Disorders |
Rituximab Lymphoproliferative Disorders Lymphoma Immunoglobulins |
Neoplasms Neoplasms by Histologic Type Immunologic Factors Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Antirheumatic Agents Pharmacologic Actions |