Spots Global Cancer Trial Database for MabRella Study: A Study to Evaluate the Safety of Switching From Intravenous to Subcutaneous Administration of Rituximab During First-Line Treatment for Lymphoma
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Trial Identification
Brief Title: MabRella Study: A Study to Evaluate the Safety of Switching From Intravenous to Subcutaneous Administration of Rituximab During First-Line Treatment for Lymphoma
Official Title: Open Label, Single-arm, Phase IIIb Clinical Trial to Evaluate the Safety of Switching From Intravenous Rituximab to Subcutaneous Rituximab During First Line Treatment for CD20+ Non-Hodgkin's Follicular Lymphoma and Diffuse Large B-cell Lymphoma.
Study ID: NCT01987505
Conditions
Interventions
Study Description
Brief Summary: This open-label, single-arm, phase IIIb study will evaluate the safety of switching from intravenous (IV) to subcutaneous (SC) administration of rituximab during first-line treatment for participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL) who have already received at least one full dose of rituximab IV. Participants with FL will be given 1400 mg rituximab SC during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). 1400 mg SC of rituximab will be given to participants with DLBCL once monthly for 4-7 cycles. Treatment duration is expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Hospital De Txagorritxu; Servicio de Hematologia, Vitoria, Alava, Spain
Hospital General de Elda; Servicio de Hematologia, Elda, Alicante, Spain
Hospital de Granollers, Servicio de Hematología, Granollers, Barcelona, Spain
Hospital Mutua de Terrassa; Servicio de Hematologia, Terrassa, Barcelona, Spain
Hospital Son Llatzer; Servicio de Hematologia, Palma de Mallorca, Islas Baleares, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Hematologia, La Coruna, LA Coruña, Spain
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Hematologia, Santiago de Compostela, LA Coruña, Spain
Complejo Hospitalario San Millan - San Pedro; Servicio Hematologia, Logroño, LA Rioja, Spain
Complejo Asistencial de León, Servicio de Hematología, León, Leon, Spain
Hospital Universitario de Fuenlabrada; Servicio de Hematologia, Fuenlabrada, Madrid, Spain
Hospital Severo Ochoa; Servicio de Hematologia, Leganes, Madrid, Spain
Hosital Universitario de Mostoles;Servicio de Hematologia, Mostoles, Madrid, Spain
Clinica Universitaria de Navarra; Servicio de Hematologia, Pamplona, Navarra, Spain
Hospital de Navarra, Servicio de Hematología, Pamplona, Navarra, Spain
Complejo Hospitalario Universitario de Vigo; Servicio de Hematologia, Vigo, Pontevedra, Spain
Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia, Santa Cruz de Tenerife, Tenerife, Spain
Hospital de Basurto; Servicio de Hematologia, Bilbao, Vizcaya, Spain
Hospital de Galdakano; Servicio de Hematologia, Galdakao, Vizcaya, Spain
Complejo Hospitalario Torrecardenas; Servicio de Hematologia, Almeria, , Spain
Hospital Universitario de Burgos, Servicio de Hematología, Burgos, , Spain
Hospital General de Castellon; Servicio de Hematologia, Castellon, , Spain
Hospital Universitario Reina Sofia; Servicio de Hematologia, Cordoba, , Spain
Hospital Universitario Virgen de las Nieves; Servicio de Hematologia, Granada, , Spain
Hospital Universitario de Gaudalajara; Hematología, Guadalajara, , Spain
Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Hematologia, Lerida, , Spain
Hospital Infanta Leonor; Servicio de Hematologia, Madrid, , Spain
Fundacion Jimenez Diaz; Servicio de Hematologia, Madrid, , Spain
Hospital Universitario Clínico San Carlos; Servicio de Hematología, Madrid, , Spain
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio Hematologia, Madrid, , Spain
Hospital Universitario Puerta de Hierro; Servicio de Hematologia, Madrid, , Spain
Hospital Universitario Principe de Asturias; Servicio de Hematología, Madrid, , Spain
Hospital Univ. Virgen de la Victoria, Malaga, , Spain
Hospital General Universitario J.M Morales Meseguer; Servicio de Hematología, Murcia, , Spain
Hospital Universitario Virgen de Arrixaca; Servicio de Hematologia, Murcia, , Spain
Complejo Hospitalario de Pontevedra; Servicio de Hematologia, Pontevedra, , Spain
Complejo Asistencial de Segovia, Segovia, , Spain
Hospital Universitario Virgen Macarena; Servicio de Hematologia, Sevilla, , Spain
Hospital Univ. Nuestra Señora de Valme; Servicio de Hematologia, Sevilla, , Spain
Hospital de Rio Hortega; Servicio de Hematologia, Valladolid, , Spain
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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