Spots Global Cancer Trial Database for Ofatumumab Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell NHL Unresponsive to Rituxtherapy
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Trial Identification
Brief Title: Ofatumumab Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell NHL Unresponsive to Rituxtherapy
Official Title: Randomized Open Label of Ofatumumab and Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell Non-Hodgkin's Lymphoma Unresponsive to Rituximab or a Rituximab-Containing Regimen During or Within Six Months of Treatment
Study ID: NCT01077518
Conditions
Study Description
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of ofatumumab and bendamustine combination therapy in patients with indolent B-cell NHL that did not respond to rituximab or a rituximab-containing regimen during or within 6 months of the last rituximab treatment.
Detailed Description: Ofatumumab is an anti-CD20 monoclonal antibody shown to have monotherapy activity in patients with follicular lymphoma that has relapsed following rituximab-containing therapy. Bendamustine was approved by FDA for the treatment of in patients with indolent B-cell Non-Hodgkin's Lymphoma (NHL) that did not respond to rituximab or a rituximab-containing regimen during or within 6 months of the last rituximab treatment. Biologics have demonstrated enhanced efficacy when added to chemotherapeutic combinations in the frontline treatment for indolent NHL. The combination of ofatumumab and bendamustine may provide additional clinical benefit and efficacy to those who no longer respond to rituximab or rituximab-containing regimens. The objective of this study is to determine the effect of ofatumumab and bendamustine combination therapy in patients with indolent B-cell NHL that did not respond to rituximab or a rituximab-containing regimen during or within 6 months of the last rituximab treatment.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Novartis Investigative Site, Tucson, Arizona, United States
Novartis Investigative Site, Beverly Hills, California, United States
Novartis Investigative Site, Palm Springs, California, United States
Novartis Investigative Site, Washington, District of Columbia, United States
Novartis Investigative Site, Atlanta, Georgia, United States
Novartis Investigative Site, Coeur d'Alene, Idaho, United States
Novartis Investigative Site, Silver Spring, Maryland, United States
Novartis Investigative Site, Detroit, Michigan, United States
Novartis Investigative Site, Saint Louis, Missouri, United States
Novartis Investigative Site, Mineola, New York, United States
Novartis Investigative Site, Rochester, New York, United States
Novartis Investigative Site, Danville, Pennsylvania, United States
Novartis Investigative Site, Philadelphia, Pennsylvania, United States
Novartis Investigative Site, Charleston, South Carolina, United States
Novartis Investigative Site, Nashville, Tennessee, United States
Novartis Investigative Site, Richmond, Virginia, United States
Novartis Investigative Site, Seattle, Washington, United States
Novartis Investigative Site, Morgantown, West Virginia, United States
Novartis Investigative Site, Capital Federal, Buenos Aires, Argentina
Novartis Investigative Site, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Novartis Investigative Site, Derqui, Pilar, Buenos Aires, Argentina
Novartis Investigative Site, La Plata, Buenos Aires, Argentina
Novartis Investigative Site, Ciudad Autonoma de Buenos Aires, , Argentina
Novartis Investigative Site, Graz, , Austria
Novartis Investigative Site, Innsbruck, , Austria
Novartis Investigative Site, Leoben, , Austria
Novartis Investigative Site, Linz, , Austria
Novartis Investigative Site, Salzburg, , Austria
Novartis Investigative Site, Steyr, , Austria
Novartis Investigative Site, Wien, , Austria
Novartis Investigative Site, Brugge, , Belgium
Novartis Investigative Site, Brussels, , Belgium
Novartis Investigative Site, Bruxelles, , Belgium
Novartis Investigative Site, Gent, , Belgium
Novartis Investigative Site, Leuven, , Belgium
Novartis Investigative Site, Calgary, Alberta, Canada
Novartis Investigative Site, Halifax, Nova Scotia, Canada
Novartis Investigative Site, Barrie, Ontario, Canada
Novartis Investigative Site, Toronto, Ontario, Canada
Novartis Investigative Site, Saskatoon, Saskatchewan, Canada
Novartis Investigative Site, Avignon cedex 9, , France
Novartis Investigative Site, Clermont-Ferrand Cedex 1, , France
Novartis Investigative Site, Grenoble cedex 9, , France
Novartis Investigative Site, La Roche sur Yon Cedex 9, , France
Novartis Investigative Site, Le Mans, , France
Novartis Investigative Site, Marseille Cedex 9, , France
Novartis Investigative Site, Nantes cedex 1, , France
Novartis Investigative Site, Nantes Cedex 2, , France
Novartis Investigative Site, Pessac cedex, , France
Novartis Investigative Site, Saint Pierre cedex, , France
Novartis Investigative Site, Saint-Denis cedex, , France
Novartis Investigative Site, Tours cedex 9, , France
Novartis Investigative Site, Mannheim, Baden-Wuerttemberg, Germany
Novartis Investigative Site, Aschaffenburg, Bayern, Germany
Novartis Investigative Site, Fuerth, Bayern, Germany
Novartis Investigative Site, Muenchen, Bayern, Germany
Novartis Investigative Site, Muenchen, Bayern, Germany
Novartis Investigative Site, Weilheim, Bayern, Germany
Novartis Investigative Site, Frankfurt, Hessen, Germany
Novartis Investigative Site, Giessen, Hessen, Germany
Novartis Investigative Site, Hanau, Hessen, Germany
Novartis Investigative Site, Kassel, Hessen, Germany
Novartis Investigative Site, Marburg, Hessen, Germany
Novartis Investigative Site, Bielefeld, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Bottrop, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Essen, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Goch, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Herford, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Leverkusen, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Paderborn, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Recklinghausen, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Kaiserslautern, Rheinland-Pfalz, Germany
Novartis Investigative Site, Koblenz, Rheinland-Pfalz, Germany
Novartis Investigative Site, Neunkirchen, Saarland, Germany
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Bremen, , Germany
Novartis Investigative Site, Alexandroupolis, , Greece
Novartis Investigative Site, Athens,, , Greece
Novartis Investigative Site, Athens, , Greece
Novartis Investigative Site, Haidari, Athens, , Greece
Novartis Investigative Site, Heraklion, Crete, , Greece
Novartis Investigative Site, Ioannina, , Greece
Novartis Investigative Site, Piraeus, , Greece
Novartis Investigative Site, Shatin, New Territories, , Hong Kong
Novartis Investigative Site, Tuen Mun, , Hong Kong
Novartis Investigative Site, Reggio Calabria, Calabria, Italy
Novartis Investigative Site, Napoli, Campania, Italy
Novartis Investigative Site, Meldola (FC), Emilia-Romagna, Italy
Novartis Investigative Site, Roma, Lazio, Italy
Novartis Investigative Site, Genova, Liguria, Italy
Novartis Investigative Site, Milano, Lombardia, Italy
Novartis Investigative Site, Milano, Lombardia, Italy
Novartis Investigative Site, Novara, Piemonte, Italy
Novartis Investigative Site, San Giovanni Rotondo, Puglia, Italy
Novartis Investigative Site, Terni, Umbria, Italy
Novartis Investigative Site, Verona, Veneto, Italy
Novartis Investigative Site, Aichi, , Japan
Novartis Investigative Site, Fukuoka, , Japan
Novartis Investigative Site, Hiroshima, , Japan
Novartis Investigative Site, Hyogo, , Japan
Novartis Investigative Site, Ibaraki, , Japan
Novartis Investigative Site, Kanagawa, , Japan
Novartis Investigative Site, Miyagi, , Japan
Novartis Investigative Site, Okayama, , Japan
Novartis Investigative Site, Osaka, , Japan
Novartis Investigative Site, Tokyo, , Japan
Novartis Investigative Site, Tokyo, , Japan
Novartis Investigative Site, Gdansk, , Poland
Novartis Investigative Site, Gdynia, , Poland
Novartis Investigative Site, Legnica, , Poland
Novartis Investigative Site, Opole, , Poland
Novartis Investigative Site, Warszawa, , Poland
Novartis Investigative Site, Warszawa, , Poland
Novartis Investigative Site, Warszawa, , Poland
Novartis Investigative Site, Warszawa, , Poland
Novartis Investigative Site, Wroclaw, , Poland
Novartis Investigative Site, Wroclaw, , Poland
Novartis Investigative Site, Hato Rey, , Puerto Rico
Novartis Investigative Site, San Juan, , Puerto Rico
Novartis Investigative Site, Chelyabinsk, , Russian Federation
Novartis Investigative Site, Kaluga, , Russian Federation
Novartis Investigative Site, Kazan, , Russian Federation
Novartis Investigative Site, Moscow, , Russian Federation
Novartis Investigative Site, Nizhniy Novgorod, , Russian Federation
Novartis Investigative Site, Novosibirsk, , Russian Federation
Novartis Investigative Site, Penza, , Russian Federation
Novartis Investigative Site, St'Petersburg, , Russian Federation
Novartis Investigative Site, St. Petersburg, , Russian Federation
Novartis Investigative Site, Tula, , Russian Federation
Novartis Investigative Site, Ufa,, , Russian Federation
Novartis Investigative Site, Volgograd, , Russian Federation
Novartis Investigative Site, Bratislava, , Slovakia
Novartis Investigative Site, Kyiv, , Ukraine
Novartis Investigative Site, Lviv, , Ukraine
Novartis Investigative Site, Makiivka, , Ukraine
Novartis Investigative Site, Plymouth, Devon, United Kingdom
Novartis Investigative Site, Northwood, Middlesex, United Kingdom
Novartis Investigative Site, Harrow, , United Kingdom
Novartis Investigative Site, Southampton, , United Kingdom
Novartis Investigative Site, Uxbridge, , United Kingdom
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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