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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: | December 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 | Recruiting |
Madrid, Spain | |
Contact: Tomás José Francisco, Dr | |
Principal Investigator: Tomás José Francisco, Dr | |
Hospital La Paz | Recruiting |
Madrid, Spain | |
Contact: Canales Miguel Ángel, Dr | |
Principal Investigator: Canales Miguel Angel, Dr | |
Hospital Clinico San Carlos | Recruiting |
Madrid, Spain | |
Contact: Martínez Rafael, Dr | |
Hospital Ramón y Cajal | Recruiting |
Madrid, Spain | |
Contact: Montalban Carlos, Dr | |
Principal Investigator: Montalban Carlos, Dr | |
Hospital de Alcorcón | Recruiting |
Alcorcón, Spain | |
Contact: Peñalver Francisco, Dr | |
Principal Investigator: Peñalver Francisco, Dr | |
Hospital Doce de Octubre | Recruiting |
Madrid, Spain | |
Contact: de la Serna Javier, Dr | |
Principal Investigator: de la Serna Javier, Dr | |
Hospital Clínic | Recruiting |
Barcelona, Spain | |
Contact: López Guillermo Armando, Dr | |
Principal Investigator: López Guillermo Armando, Dr | |
Hospital de la santa Creu i Sant Pau | Recruiting |
Barcelona, Spain | |
Contact: Delgado Julio, Dr | |
Principal Investigator: Delgado Julio, Dr | |
Hospital germans Trias i Pujol | Recruiting |
Badalona, Spain | |
Contact: Sancho Juan Manuel, Dr | |
Principal Investigator: Sancho Juan Manuel, Dr | |
Hospital del Mar | Recruiting |
Barcelona, Spain | |
Contact: Salar Antonio, Dr | |
Principal Investigator: Salar Antonio, Dr | |
Hospital La Fe | Recruiting |
Valencia, Spain | |
Contact: Jarque Isidro, Dr | |
Principal Investigator: Jarque Isidro, Dr | |
Hospital Clínico | Recruiting |
Valencia, Spain | |
Contact: Terol María José, Dr | |
Principal Investigator: Terol María José, Dr | |
Hospital General | Recruiting |
V alencia, Spain | |
Contact: Carbonell Félix, Dr | |
Principal Investigator: Carbonell Félix, Dr | |
Hoaspital Marqués de Valdecilla | Recruiting |
Santander, Spain | |
Contact: Conde Eulogio, Dr | |
Principal Investigator: Conde Eulogio, Dr | |
Hospital Juan Canalejo | Recruiting |
La Coruña, Spain | |
Contact: Deben Guillermo, Dr | |
Principal Investigator: Deben Guillermo, Dr | |
Hospital Clínico Universitario | Recruiting |
Santiago de Compostela, Spain | |
Contact: Bello . José Luis, Dr | |
Principal Investigator: Bello . José Luis, Dr | |
Hospital Dr Pesset | Recruiting |
Valencia, Spain | |
Contact: Ferrer Secundino, Dr | |
Principal Investigator: Ferrer Secundino, Dr | |
Hospital Clínico | Recruiting |
Salamanca, Spain | |
Contact: Caballero Dolores, Dr | |
Principal Investigator: Caballero Dolores, Dr | |
Hospital de Donostia | Recruiting |
San Sebastián, Spain | |
Contact: Marín Julián, Dr | |
Principal Investigator: Marín Julián, Dr | |
Hospital Virgen de la Arrixaca | Recruiting |
Murcia, Spain | |
Contact: Moraleda José María, Dr | |
Principal Investigator: Moraleda José María, Dr | |
Hospital son Dureta | Recruiting |
Palma de Mallorca, Spain | |
Contact: Besalduch Joan, Dr | |
Principal Investigator: Besalduch Joan, Dr |
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: | February 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00662948 History of Changes |
Health Authority: | Spain: Ministry of Health |
Folicular Lymphoma Consolidation Maintenance |
Antibodies, Monoclonal Lymphatic Diseases Antibodies Immunoproliferative Disorders Immunologic Factors |
Rituximab Antirheumatic Agents Lymphoproliferative Disorders Lymphoma Immunoglobulins |
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Immunologic Factors Antineoplastic Agents Rituximab Physiological Effects of Drugs Pharmacologic Actions |
Antibodies, Monoclonal Lymphatic Diseases Neoplasms Therapeutic Uses Lymphoproliferative Disorders Antirheumatic Agents Lymphoma |