Spots Global Cancer Trial Database for Ofatumumab Added to Fludarabine-Cyclophosphamide vs Fludarabine-Cyclophosphamide Combination in Relapsed Subjects With Chronic Lymphocytic Leukemia
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Trial Identification
Brief Title: Ofatumumab Added to Fludarabine-Cyclophosphamide vs Fludarabine-Cyclophosphamide Combination in Relapsed Subjects With Chronic Lymphocytic Leukemia
Official Title: A Phase III, Open Label, Randomized Trial of Ofatumumab Added to Fludarabine-Cyclophosphamide vs. Fludarabine-Cyclophosphamide Combination in Subjects With Relapsed Chronic Lymphocytic Leukemia
Study ID: NCT00824265
Conditions
Study Description
Brief Summary: The purpose of this study was to evaluate the safety and efficacy of ofatumumab added to fludarabine-cyclophosphamide in patients with relapsed Chronic Lymphocytic Leukemia (CLL).
Detailed Description: Fludarabine is currently approved for treatment of relapsed Chronic Lymphocytic Leukemia. Studies have shown that drugs in combination with fludarabine have shown more effectiveness than fludarabine alone. The addition of ofatumumab to fludarabine-cyclophosphamide combination offers potentially a more effective therapy, without additional toxicity. The objective of this study was to determine the effect of ofatumumab added to fludarabine and cyclophosphamide in patients with Chronic Lymphocytic Leukemia who have responded previously to therapy but later develop progressive disease and require additional therapy.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Novartis Investigative Site, Boca Raton, Florida, United States
Novartis Investigative Site, Chicago, Illinois, United States
Novartis Investigative Site, Clinton, Maryland, United States
Novartis Investigative Site, Kansas City, Missouri, United States
Novartis Investigative Site, Saint Louis, Missouri, United States
Novartis Investigative Site, Memphis, Tennessee, United States
Novartis Investigative Site, Brasilia, Goiás, Brazil
Novartis Investigative Site, Porto Alegre, Rio Grande Do Sul, Brazil
Novartis Investigative Site, Sao Paulo, São Paulo, Brazil
Novartis Investigational Site, Porto Alegre, , Brazil
Novartis Investigative Site, Rio de Janeiro, , Brazil
Novartis Investigation Site, Rio de Janeiro, , Brazil
Novartis Investigative Site, Rio de Janeiro, , Brazil
Novartis Investigational Site, Sao Paulo, , Brazil
Novartis Investigative Site, Pleven, , Bulgaria
Novartis Investigative Site, Plovdiv, , Bulgaria
Novartis Investigative Site, Sofia, , Bulgaria
Novartis Investigational Site, Sofia, , Bulgaria
Novartis Investigational Site, Sofia, , Bulgaria
Novartis Investigative Site, Sofia, , Bulgaria
Novartis Investigative Site, Varna, , Bulgaria
Novartis Investigative Site, New Westminster, British Columbia, Canada
Novartis Investigative Site, Kitchener, Ontario, Canada
Novartis Investigative Site, Newmarket, Ontario, Canada
Novartis Investigative Site, Ottawa, Ontario, Canada
Novartis Investigative Site, Greenfield Park, Quebec, Canada
Novartis Investigative Site, Montreal, Quebec, Canada
Novartis Investigative Site, Sherbrooke, Quebec, Canada
Novartis Investigative Site, Saskatoon, Saskatchewan, Canada
Novartis Investigative Site, Karlsruhe, Baden-Wuerttemberg, Germany
Novartis Investigative Site, Stuttgart, Baden-Wuerttemberg, Germany
Novartis Investigative Site, Stuttgart, Baden-Wuerttemberg, Germany
Novartis Investigative Site, Villingen-Schwenningen, Baden-Wuerttemberg, Germany
Novartis Investigative Site, Muenchen, Bayern, Germany
Novartis Investigative Site, Frankfurt, Hessen, Germany
Novartis Investigative Site, Kassel, Hessen, Germany
Novartis Investigative Site, Hannover, Niedersachsen, Germany
Novartis Investigative Site, Lehrte, Niedersachsen, Germany
Novartis Investigative Site, Essen, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Moenchengladbach-Rheydt, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Muenster, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Saarbruecken, Saarland, Germany
Novartis Investigative Site, Dresden, Sachsen, Germany
Novartis Investigational Site, Hamburg, , Germany
Novartis Investigational Site, Lubeck, , Germany
Novartis Investigative Site, Athens,, , Greece
Novartis Investigative Site, Athens, , Greece
Novartis Investigative Site, Thessaloniki, , Greece
Novartis Investigative Site, Thessaloniki, , Greece
Novartis Investigative Site, Bangalore, , India
Novartis Investigative Site, Mumbai, , India
Novartis Investigative Site, Mumbai, , India
Novartis Investigative Site, New Delhi, , India
Novartis Investigative Site, Pune, , India
Novartis Investigative Site, Vadodara, , India
Novartis Investigative Site, Potenza, Basilicata, Italy
Novartis Investigative Site, Roma, Lazio, Italy
Novartis Investigative Site, Roma, Lazio, Italy
Novartis Investigative Site, Genova, Liguria, Italy
Novartis Investigative Site, Pavia, Lombardia, Italy
Novartis Investigative Site, Ascoli Piceno, Marche, Italy
Novartis Investigative Site, Alessandria, Piemonte, Italy
Novartis Investigative Site, Novara, Piemonte, Italy
Novartis Investigative Site, Catania, Sicilia, Italy
Novartis Investigative Site, Palermo, Sicilia, Italy
Novartis Investigative Site, Guadalajara, Jalisco, Mexico
Novartis Investigative Site, Monterrey, Nuevo León, Mexico
Novartis Investigative Site, Monterrey, Nuevo León, Mexico
Novartis Investigative Site, Mexico City, , Mexico
Novartis Investigative Site, Amersfoort, , Netherlands
Novartis Investigative Site, Den Haag, , Netherlands
Novartis Investigative Site, Nijmegen, , Netherlands
Novartis Investigative Site, Rotterdam, , Netherlands
Novartis Investigative Site, Rotterdam, , Netherlands
Novartis Investigative Site, Bialystok, , Poland
Novartis Investigative Site, Chorzow, , Poland
Novartis Investigative Site, Krakow, , Poland
Novartis Investigative Site, Lodz, , Poland
Novartis Investigative Site, Opole, , 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, Bucharest, , Romania
Novartis Investigative Site, Bucharest, , Romania
, Iasi, , Romania
Novartis Investigative Site, Iasi, , Romania
Novartis Investigative Site, Kazan, , Russian Federation
Novartis Investigative Site, Moscow, , Russian Federation
Novartis Investigative Site, Moscow, , Russian Federation
Novartis Investigative Site, Moscow, , Russian Federation
Novartis Investigative Site, Novosibirsk, , Russian Federation
Novartis Investigative Site, St'Petersburg, , Russian Federation
Novartis Investigative Site, St. Petersburg, , Russian Federation
Novartis Investigative Site, Barcelona, , Spain
Novartis Investigative Site, Barcelona, , Spain
Novartis Investigative Site, Barcelona, , Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Salamanca, , Spain
Novartis Investigative Site, Sevilla, , Spain
Novartis Investigative Site, Taichung, , Taiwan
Novartis Investigative Site, Taipei city, , Taiwan
Novartis Investigative Site, Taipei, , Taiwan
Novartis Investigational Site, Taipei, , Taiwan
Novartis Investigative Site, Bangkok, , Thailand
Novartis Investigative Site, Bangkok, , Thailand
Novartis Investigative Site, Bangkok, , Thailand
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, Kyiv, , Ukraine
Novartis Investigative Site, Lviv, , Ukraine
Novartis Investigative Site, Makiivka, , Ukraine
Novartis Investigational Site, Simferopil, , Ukraine
Novartis Investigative Site, Vinnitsa, , Ukraine
Novartis Investigational Site, Zhytomyr, , Ukraine
Novartis Investigative Site, Birmingham, , United Kingdom
Novartis Investigative Site, Bradford, , United Kingdom
Novartis Investigative Site, Burton on Trent, , United Kingdom
Novartis Investigative Site, Cottingham, , United Kingdom
Novartis Investigative Site, Dudley, , United Kingdom
Novartis Investigative Site, Glasgow, , United Kingdom
Novartis Investigative Site, Leicester, , United Kingdom
Novartis Investigative Site, London, , United Kingdom
Novartis Investigative Site, Manchester, , United Kingdom
Novartis Investigative Site, Sutton, , United Kingdom
Novartis Investigative Site, Swindon, , United Kingdom
Novartis Investigative Site, Truro, , United Kingdom
Novartis Investigative Site, Uxbridge, , United Kingdom
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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