Spots Global Cancer Trial Database for Ofatumumab Maintenance Treatment vs No Further Treatment in Relapsed CLL Responding to Induction Therapy
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Trial Identification
Brief Title: Ofatumumab Maintenance Treatment vs No Further Treatment in Relapsed CLL Responding to Induction Therapy
Official Title: A Phase III, Open Label, Randomized, Multicenter Trial of Ofatumumab Maintenance Treatment Versus no Further Treatment in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL) Who Have Responded to Induction Therapy
Study ID: NCT01039376
Conditions
Study Description
Brief Summary: The purpose of this study was to determine if maintenance therapy with ofatumumab would prolong remission in patients with CLL who have responded to second or third line treatment. This study would also evaluate the safety of ofatumumab maintenance compared to observation (the current standard of care). This study was co-developed with the HOVON and NORDIC CLL group and would be conducted as a collaborative effort with GSK.
Detailed Description: The study met its primary objective at the protocol defined interim analysis (data cut-off 19-Jun-2014). The protocol-defined final analysis of the primary endpoint was performed when 280 PFS events were reached (data cut-off 20-Feb-2017).
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Novartis Investigative Site, Gilbert, Arizona, United States
Novartis Investigative Site, Tucson, Arizona, United States
Novartis Investigative Site, Tucson, Arizona, United States
Novartis Investigative Site, Jonesboro, Arkansas, United States
Novartis Investigative Site, Berkeley, California, United States
Novartis Investigative Site, La Verne, California, United States
Novartis Investigative Site, Sacramento, California, United States
Novartis Investigative Site, Sacramento, California, United States
Novartis Investigative Site, San Pablo, California, United States
Novartis Investigative Site, Hartford, Connecticut, United States
Novartis Investigative Site, Gainesville, Florida, United States
Novartis Investigative Site, Lake Worth, Florida, United States
Novartis Investigative Site, Orlando, Florida, United States
Novartis Investigative Site, Pembroke Pines, Florida, United States
Novartis Investigative Site, West Palm Beach, Florida, United States
Novartis Investigative Site, Macon, Georgia, United States
Novartis Investigative Site, Savannah, Georgia, United States
Novartis Investigative Site, Post Falls, Idaho, United States
Novartis Investigative Site, Indianapolis, Indiana, United States
Novartis Investigative Site, Iowa City, Iowa, United States
Novartis Investigative Site, Westwood, Kansas, United States
Novartis Investigative Site, Metairie, Louisiana, United States
Novartis Investigative Site, Cumberland, Maryland, United States
Novartis Investigative Site, Hagerstown, Maryland, United States
Novartis Investigative Site, Worcester, Massachusetts, United States
Novartis Investigative Site, Detroit, Michigan, United States
Novartis Investigative Site, Saint Louis, Missouri, United States
Novartis Investigative Site, Springfield, Missouri, United States
Novartis Investigative Site, Henderson, Nevada, United States
Novartis Investigative Site, New Brunswick, New Jersey, United States
Novartis Investigative Site, Albuquerque, New Mexico, United States
Novartis Investigative Site, Albuquerque, New Mexico, United States
Novartis Investigative Site, Mineola, New York, United States
Novartis Investigative Site, Rochester, New York, United States
Novartis Investigative Site, Chapel Hill, North Carolina, United States
Novartis Investigative Site, Durham, North Carolina, United States
Novartis Investigative Site, Philadelphia, Pennsylvania, United States
Novartis Investigative Site, Greenville, South Carolina, United States
Novartis Investigative Site, Chattanooga, Tennessee, United States
Novartis Investigative Site, Knoxville, Tennessee, United States
Novartis Investigative Site, Memphis, Tennessee, United States
Novartis Investigative Site, Orem, Utah, United States
Novartis Investigative Site, Salt Lake City, Utah, 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, Rosario, Santa Fe, Argentina
Novartis Investigative Site, Ciudad Autonoma de Buenos Aires, , Argentina
Novartis Investigative Site, Darlinghurst, New South Wales, Australia
Novartis Investigative Site, Randwick, New South Wales, Australia
Novartis Investigative Site, Clayton, Victoria, Australia
Novartis Investigative Site, East Melbourne, Victoria, Australia
Novartis Investigative Site, Parkville, Victoria, Australia
Novartis Investigative Site, Antwerpen, , Belgium
Novartis Investigative Site, Antwerpen, , Belgium
Novartis Investigative Site, Brugge, , Belgium
Novartis Investigative Site, Brussels, , Belgium
Novartis Investigative Site, Gent, , Belgium
Novartis Investigative Site, Hasselt, , Belgium
Novartis Investigative Site, Roeselare, , Belgium
Novartis Investigative Site, Wilrijk, , Belgium
Novartis Investigative Site, Salvador, Bahía, Brazil
Novartis Investigative Site, Goiania - GO, Goiás, Brazil
Novartis Investigative Site, Porto Alegre, Rio Grande Do Sul, Brazil
Novartis Investigative Site, Barretos, São Paulo, Brazil
Novartis Investigative Site, Sao Paulo, São Paulo, Brazil
Novartis Investigative Site, Sao Paulo, São Paulo, Brazil
Novartis Investigative Site, Calgary, Alberta, Canada
Novartis Investigative Site, Kitchener, Ontario, Canada
Novartis Investigative Site, Toronto, Ontario, Canada
Novartis Investigative Site, Montreal, Quebec, Canada
Novartis Investigative Site, Montreal, Quebec, Canada
Novartis Investigative Site, Sherbrooke, Quebec, Canada
Novartis Investigative Site, Saskatoon, Saskatchewan, Canada
Novartis Investigative Site, Brno, , Czechia
Novartis Investigative Site, Hradec Kralove, , Czechia
Novartis Investigative Site, Olomouc, , Czechia
Novartis Investigative Site, Pelhrimov, , Czechia
Novartis Investigative Site, Praha 10, , Czechia
Novartis Investigative Site, Herlev, , Denmark
Novartis Investigative Site, Kobenhavn, , Denmark
Novartis Investigative Site, Roskilde, , Denmark
Novartis Investigative Site, Helsinki, , Finland
Novartis Investigative Site, Jyvaskyla, , Finland
Novartis Investigative Site, Pori, , Finland
Novartis Investigative Site, Tampere, , Finland
Novartis Investigative Site, Turku, , Finland
Novartis Investigative Site, Blois cedex, , France
Novartis Investigative Site, Caen cedex 5, , France
Novartis Investigative Site, Clermont-Ferrand Cedex 1, , France
Novartis Investigative Site, Dijon, , France
Novartis Investigative Site, Lille cedex, , France
Novartis Investigative Site, Marseille Cedex 9, , France
Novartis Investigative Site, Mulhouse, , France
Novartis Investigative Site, Pessac cedex, , France
Novartis Investigative Site, Saint Pierre cedex, , France
Novartis Investigative Site, Strasbourg cedex, , France
Novartis Investigative Site, Toulouse cedex 9, , France
Novartis Investigative Site, Vandoeuvre-Les-Nancy, , France
Novartis Investigative Site, Athens,, , Greece
Novartis Investigative Site, Athens, , Greece
Novartis Investigative Site, Piraeus, , Greece
Novartis Investigative Site, Thessaloniki, , Greece
Novartis Investigative Site, Thessaloniki, , Greece
Novartis Investigative Site, Budapest, , Hungary
Novartis Investigative Site, Debrecen, , Hungary
Novartis Investigative Site, Kecskemet, , Hungary
Novartis Investigative Site, Szeged, , Hungary
Novartis Investigative Site, Ahmedabad, , India
Novartis Investigative Site, Mumbai, , India
Novartis Investigative Site, Mumbai, , India
Novartis Investigative Site, Pune, , India
Novartis Investigative Site, Afula, , Israel
Novartis Investigative Site, Haifa, , Israel
Novartis Investigative Site, Haifa, , Israel
Novartis Investigative Site, Jerusalem, , Israel
Novartis Investigative Site, Jerusalem, , Israel
Novartis Investigative Site, Kfar Saba, , Israel
Novartis Investigative Site, Nahariya, , Israel
Novartis Investigative Site, Petach-Tikva, , Israel
Novartis Investigative Site, Ramat Gan, , Israel
Novartis Investigative Site, Rehovot, , Israel
Novartis Investigative Site, Tel-Aviv, , Israel
Novartis Investigative Site, Zrifin, , Israel
Novartis Investigative Site, Modena, Emilia-Romagna, Italy
Novartis Investigative Site, Piacenza, Emilia-Romagna, Italy
Novartis Investigative Site, Roma, Lazio, Italy
Novartis Investigative Site, Novara, Piemonte, Italy
Novartis Investigative Site, Torino, Piemonte, Italy
Novartis Investigative Site, Pisa, Toscana, Italy
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Amersfoort, , Netherlands
Novartis Investigative Site, Amsterdam, , Netherlands
Novartis Investigative Site, Amsterdam, , Netherlands
Novartis Investigative Site, Amsterdam, , Netherlands
Novartis Investigative Site, Blaricum, , Netherlands
Novartis Investigative Site, Breda, , Netherlands
Novartis Investigative Site, Den Bosch, , Netherlands
Novartis Investigative Site, Den Haag, , Netherlands
Novartis Investigative Site, Deventer, , Netherlands
Novartis Investigative Site, Dordrecht, , Netherlands
Novartis Investigative Site, Enschede, , Netherlands
Novartis Investigative Site, Groningen, , Netherlands
Novartis Investigative Site, Hoofddorp, , Netherlands
Novartis Investigative Site, Leiden, , Netherlands
Novartis Investigative Site, Maastricht, , Netherlands
Novartis Investigative Site, Rotterdam, , Netherlands
Novartis Investigative Site, Rotterdam, , Netherlands
Novartis Investigative Site, Rotterdam, , Netherlands
Novartis Investigative Site, Sittard-geleen, , Netherlands
Novartis Investigative Site, Tilburg, , Netherlands
Novartis Investigative Site, Oslo, , Norway
Novartis Investigative Site, Bialystok, , Poland
Novartis Investigative Site, Chorzow, , Poland
Novartis Investigative Site, Slupsk, , Poland
Novartis Investigative Site, Szczecin, , 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, San Juan, , Puerto Rico
Novartis Investigative Site, Kazan, , Russian Federation
Novartis Investigative Site, Moscow, , Russian Federation
Novartis Investigative Site, Moscow, , 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, St. Petersburg, , Russian Federation
Novartis Investigative Site, Volgograd, , Russian Federation
Novartis Investigative Site, Hospitalet de Llobregat (Barcelona), , Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Salamanca, , Spain
Novartis Investigative Site, Sevilla, , Spain
Novartis Investigative Site, Toledo, , Spain
Novartis Investigative Site, Zaragoza, , Spain
Novartis Investigative Site, Goteborg, , Sweden
Novartis Investigative Site, Linkoping, , Sweden
Novartis Investigative Site, Lulea, , Sweden
Novartis Investigative Site, Orebro, , Sweden
Novartis Investigative Site, Stockholm, , Sweden
Novartis Investigative Site, Uppsala, , Sweden
Novartis Investigative Site, Ankara, , Turkey
Novartis Investigative Site, Ankara, , Turkey
Novartis Investigative Site, Istanbul, , Turkey
Novartis Investigative Site, Izmir, , Turkey
Novartis Investigative Site, Izmir, , Turkey
Novartis Investigative Site, Cherkasy, , Ukraine
Novartis Investigative Site, Dnipropetrovsk, , Ukraine
Novartis Investigative Site, Kharkiv, , Ukraine
Novartis Investigative Site, Khmelnytskyi, , Ukraine
Novartis Investigative Site, Kyiv, , Ukraine
Novartis Investigative Site, Lviv, , Ukraine
Novartis Investigative Site, Makiivka, , Ukraine
Novartis Investigative Site, Vinnitsa, , Ukraine
Novartis Investigative Site, Zhytomyr, , Ukraine
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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