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Sponsored by: |
Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas |
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Information provided by: | Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas |
ClinicalTrials.gov Identifier: | NCT00722930 |
To evaluate the complete clinical response rate according to the International Working Group criteria with a consolidation treatment with 90Y-ibritumomab tiuxetan (Zevalin®) in patients with high-risk follicular lymphoma with either partial or complete response to R-CHOP induction chemotherapy
Condition | Intervention | Phase |
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Follicular Lymphoma |
Drug: Y90 Ibritumomab Tiuxetan |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Consolidation Treatment With Y90-Ibritumomab Tiuxetan In Patients With High-Risk Follicular Lymphoma With Either Partial Or Complete Response To R-Chop Induction Chemotherapy |
Estimated Enrollment: | 38 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | April 2013 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1. Consolidation with Y90 Ibritumomab Tiuxetan: Experimental
1. Consolidation with Y90 Ibritumomab Tiuxetan
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Drug: Y90 Ibritumomab Tiuxetan
Consolidation with Y90 Ibritumomab Tiuxetan
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A suitable bone marrow reserve:
Suitable hepatic, renal and cardiac function:
Exclusion Criteria:
Contact: Mariano Provencio, MD | +34-91-344-57-60 | mprovenciop@yahoo.es |
Contact: Sandra Cerdeira, Secretary | 34 91 3445131 | secretariatecnica@grupolinfomas.es |
Spain | |
Hospital Virgen de las Nieves | Active, not recruiting |
Granada, Spain | |
Clínica Ruber Internacional | Active, not recruiting |
Madrid, Spain | |
Clinia Puerta de Hierro | Recruiting |
Madrid, Spain | |
Principal Investigator: Mariano Provencio, MD | |
Complejo Hospitalario de Pontevedra | Active, not recruiting |
Pontevedra, Spain | |
Hospital Universitario Virgen Macarena | Active, not recruiting |
Sevilla, Spain | |
Hospital Virgen de la Salud de Toledo | Active, not recruiting |
Toledo, Spain | |
Hospital Universitario La Fe | Active, not recruiting |
Valencia, Spain | |
Spain, Malaga | |
Hospital Virgen de la Victoria | Active, not recruiting |
Málaga, Malaga, Spain | |
Spain, San Sebastián | |
Instituto Oncológico San Sebastián | Active, not recruiting |
Donostia, San Sebastián, Spain | |
Spain, Santa Cruz de Tenerife | |
Hospital Universitario de Canarias | Active, not recruiting |
La Laguna, Santa Cruz de Tenerife, Spain | |
Spain, Tarragona | |
Hospital Sant Joan de Reus | Active, not recruiting |
Reus, Tarragona, Spain |
Principal Investigator: | Mariano Provencio, MD | Clínica Puerta de Hierro |
Responsible Party: | Clínica Puerta de Hierro, Servicio de Oncología Médica ( Dr. Mariano Provencio ) |
Study ID Numbers: | GOTEL-FL1LC-0701, Eudra-CT 2007-003091-19 |
Study First Received: | July 25, 2008 |
Last Updated: | July 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00722930 History of Changes |
Health Authority: | Spain: Spanish Agency of Medicines |
Follicular Lymphoma High-risk FLIPI R-CHOP GOTEL Partial |
Complete Response R-CHOP Induction Chemotherapy |
Antibodies, Monoclonal Lymphatic Diseases Antibodies Immunoproliferative Disorders Immunologic Factors Lymphoma, Follicular |
Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Follicular Lymphoma Lymphoma Immunoglobulins |
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Immunologic Factors Physiological Effects of Drugs Lymphoma, Follicular Pharmacologic Actions |
Antibodies, Monoclonal Lymphatic Diseases Neoplasms Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |