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Spots Global Cancer Trial Database for Single Agent Ofatumumab Vs. Single Agent Rituximab in Indolent B-Cell Non Hodgkin Lymphoma Relapsed After Rituximab-Containing Therapy

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Trial Identification

Brief Title: Single Agent Ofatumumab Vs. Single Agent Rituximab in Indolent B-Cell Non Hodgkin Lymphoma Relapsed After Rituximab-Containing Therapy

Official Title: Phase III Randomized, Open Label Study of Single Agent Ofatumumab Vs. Single Agent Rituximab in Indolent B-Cell Non Hodgkin Lymphoma Relapsed After Rituximab-Containing Therapy

Study ID: NCT01200589

Study Description

Brief Summary: This was a multi-center, parallel, active comparator controlled, open-label, randomized (1:1) phase III study of single agent ofatumumab compared to single agent rituximab in subjects with rituximab-sensitive indolent B-cell non hodgkin lymphoma that has relapsed at least 6 months after completing treatment with single agent rituximab or a rituximab-containing regimen. Subjects must have attained a Complete Response or Partial Response to their last prior rituximab containing therapy lasting at least six months beyond the end of rituximab therapy. Subjects were to receive four weekly doses of single agent ofatumumab (1000 mg) or rituximab (375 mg/m2), followed by ofatumumab (1000 mg) or rituximab (375 mg/m2) every 2 months for four additional doses. Therefore, subjects were to receive a total of eight doses of anti-CD20 antibody over 9 months. Subjects were evaluated for response after completion of the first four doses of therapy, after six doses of therapy, and after completion of study therapy. Subjects were to be followed until the end of the designated follow-up period (total study duration of 200 weeks) or until they meet the withdrawal criteria. The primary objective of the study OMB157D 2303 was to demonstrate the efficacy of Arzerra based on the primary endpoint (Progression-free survival (PFS) as assessed by the IRC) in patients with Indolent B-cell Non-Hodgkin's Lymphoma Relapsed After Rituximab-Containing Regimen. The Independent Data Monitoring Committee (IDMC) met on November 22, 2015 and recommended the termination of the study due to futility (cut-off date = 12Jun2015). The IDMC reviewed analyses results for progression free survival (PFS), overall response rate (ORR), and overall survival (OS). Novartis accepted this recommendation and the study was closed. Final analysis was performed (cut-off date =19 Dec 2016). As the study was stopped for futility, the primary objective was not met and some secondary endpoints, supportive of primary objective (Duration of Response (DOR), time to next therapy, and pharmacokinetics) were removed as secondary end points.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Novartis Investigative Site, Anchorage, Alaska, United States

Novartis Investigative Site, Gilbert, Arizona, United States

Novartis Investigative Site, Hot Springs, Arkansas, United States

Novartis Investigative Site, Greenbrae, California, United States

Novartis Investigative Site, Monterey, California, United States

Novartis Investigative Site, Pleasant Hill, California, United States

Novartis Investigative Site, Rancho Mirage, California, United States

Novartis Investigative Site, Salinas, California, United States

Novartis Investigative Site, San Diego, California, United States

Novartis Investigative Site, San Pablo, California, United States

Novartis Investigative Site, Santa Monica, California, United States

Novartis Investigative Site, New Milford, Connecticut, United States

Novartis Investigative Site, Torrington, Connecticut, United States

Novartis Investigative Site, Lakeland, Florida, United States

Novartis Investigative Site, Orlando, Florida, United States

Novartis Investigative Site, Pembroke Pines, Florida, United States

Novartis Investigative Site, Port Saint Lucie, Florida, United States

Novartis Investigative Site, West Palm Beach, Florida, United States

Novartis Investigative Site, Macon, Georgia, United States

Novartis Investigative Site, Marietta, Georgia, United States

Novartis Investigative Site, Evanston, Illinois, United States

Novartis Investigative Site, Peoria, Illinois, United States

Novartis Investigative Site, Quincy, Illinois, United States

Novartis Investigative Site, Skokie, Illinois, United States

Novartis Investigative Site, Anderson, Indiana, United States

Novartis Investigative Site, Indianapolis, Indiana, United States

Novartis Investigative Site, Ames, Iowa, United States

Novartis Investigative Site, Mount Sterling, Kentucky, United States

Novartis Investigative Site, Metairie, Louisiana, United States

Novartis Investigative Site, Shreveport, Louisiana, United States

Novartis Investigative Site, Waterville, Maine, United States

Novartis Investigative Site, Silver Spring, Maryland, United States

Novartis Investigative Site, Grand Rapids, Michigan, United States

Novartis Investigative Site, Kalamazoo, Michigan, United States

Novartis Investigative Site, Jackson, Mississippi, United States

Novartis Investigative Site, Columbia, Missouri, United States

Novartis Investigative Site, Kansas City, Missouri, United States

Novartis Investigative Site, Saint Joseph, Missouri, United States

Novartis Investigative Site, Springfield, Missouri, United States

Novartis Investigative Site, Bozeman, Montana, United States

Novartis Investigative Site, Lincoln, Nebraska, United States

Novartis Investigative Site, Lincoln, Nebraska, United States

Novartis Investigative Site, Albuquerque, New Mexico, United States

Novartis Investigative Site, Albuquerque, New Mexico, United States

Novartis Investigative Site, Lake Success, New York, United States

Novartis Investigative Site, Mount Kisco, New York, United States

Novartis Investigative Site, Greensboro, North Carolina, United States

Novartis Investigative Site, Bismarck, North Dakota, United States

Novartis Investigative Site, Canton, Ohio, United States

Novartis Investigative Site, Canton, Ohio, United States

Novartis Investigative Site, Portland, Oregon, United States

Novartis Investigative Site, Danville, Pennsylvania, United States

Novartis Investigative Site, Ephrata, Pennsylvania, United States

Novartis Investigative Site, Lancaster, Pennsylvania, United States

Novartis Investigative Site, Willow Grove, Pennsylvania, United States

Novartis Investigative Site, Chattanooga, Tennessee, United States

Novartis Investigative Site, Germantown, Tennessee, United States

Novartis Investigative Site, Knoxville, Tennessee, United States

Novartis Investigative Site, Fort Sam Houston, Texas, United States

Novartis Investigative Site, Houston, Texas, United States

Novartis Investigative Site, Ogden, Utah, United States

Novartis Investigative Site, Salt Lake City, Utah, United States

Novartis Investigative Site, Fredericksburg, Virginia, United States

Novartis Investigative Site, Kennewick, Washington, United States

Novartis Investigative Site, Kirkland, Washington, United States

Novartis Investigative Site, Mount Vernon, Washington, United States

Novartis Investigative Site, Seattle, Washington, United States

Novartis Investigative Site, Seattle, Washington, United States

Novartis Investigative Site, Sequim, Washington, United States

Novartis Investigative Site, Spokane, Washington, United States

Novartis Investigative Site, Antwerpen, , Belgium

Novartis Investigative Site, Antwerpen, , Belgium

Novartis Investigative Site, Brugge, , Belgium

Novartis Investigative Site, Brussels, , Belgium

Novartis Investigative Site, Bruxelles, , Belgium

Novartis Investigative Site, Kortrijk, , Belgium

Novartis Investigative Site, Leuven, , Belgium

Novartis Investigative Site, Wilrijk, , Belgium

Novartis Investigative Site, Salvador, Bahía, Brazil

Novartis Investigative Site, Betim, Minas Gerais, Brazil

Novartis Investigative Site, Curitiba, Paraná, Brazil

Novartis Investigative Site, Porto Alegre, Rio Grande Do Sul, Brazil

Novartis Investigative Site, Barretos, São Paulo, Brazil

Novartis Investigative Site, Jau, São Paulo, Brazil

Novartis Investigative Site, Sao Paulo, São Paulo, Brazil

Novartis Investigative Site, Sao Paulo, São Paulo, Brazil

Novartis Investigative Site, Sao Paulo, São Paulo, Brazil

Novartis Investigative Site, Sao Paulo, São Paulo, Brazil

Novartis Investigative Site, Rio de Janeiro, , Brazil

Novartis Investigative Site, Rio de Janeiro, , Brazil

Novartis Investigative Site, Pleven, , Bulgaria

Novartis Investigative Site, Plovdiv, , Bulgaria

Novartis Investigative Site, Sofia, , Bulgaria

Novartis Investigative Site, Sofia, , Bulgaria

Novartis Investigative Site, Sofia, , Bulgaria

Novartis Investigative Site, Varna, , Bulgaria

Novartis Investigative Site, Moncton, New Brunswick, Canada

Novartis Investigative Site, Kitchener, Ontario, Canada

Novartis Investigative Site, Sherbrooke, Quebec, Canada

Novartis Investigative Site, Quebec, , Canada

Novartis Investigative Site, Guangzhou, Guangdong, China

Novartis Investigative Site, Guangzhou, Guangdong, China

Novartis Investigative Site, Hangzhou, Zhejiang, China

Novartis Investigative Site, Beijing, , China

Novartis Investigative Site, Beijing, , China

Novartis Investigative Site, Beijing, , China

Novartis Investigative Site, Beijing, , China

Novartis Investigative Site, Beijing, , China

Novartis Investigative Site, Shanghai, , China

Novartis Investigative Site, Shanghai, , China

Novartis Investigative Site, Tianjin, , China

Novartis Investigative Site, Brno, , Czechia

Novartis Investigative Site, Hradec Kralove, , Czechia

Novartis Investigative Site, Ostrava, , Czechia

Novartis Investigative Site, Praha 2, , Czechia

Novartis Investigative Site, Boulogne sur Mer Cedex, , France

Novartis Investigative Site, Clermont-Ferrand Cedex 1, , France

Novartis Investigative Site, La Roche sur Yon Cedex 9, , France

Novartis Investigative Site, Le Mans, , France

Novartis Investigative Site, Montpellier cedex 5, , France

Novartis Investigative Site, Pessac cedex, , France

Novartis Investigative Site, Budapest, , Hungary

Novartis Investigative Site, Debrecen, , Hungary

Novartis Investigative Site, Gyor, , Hungary

Novartis Investigative Site, Szeged, , Hungary

Novartis Investigative Site, Aichi, , Japan

Novartis Investigative Site, Kyoto, , Japan

Novartis Investigative Site, Miyagi, , Japan

Novartis Investigative Site, Nagasaki, , Japan

Novartis Investigative Site, Saitama, , Japan

Novartis Investigative Site, Tochigi, , Japan

Novartis Investigative Site, Tokyo, , Japan

Novartis Investigative Site, Tokyo, , Japan

Novartis Investigative Site, Busan, , Korea, Republic of

Novartis Investigative Site, Seoul, , Korea, Republic of

Novartis Investigative Site, Seoul, , Korea, Republic of

Novartis Investigative Site, Miraflores, Lima, Peru

Novartis Investigative Site, San Isidro, Lima, Peru

Novartis Investigative Site, Lima, , Peru

Novartis Investigative Site, Lima, , Peru

Novartis Investigative Site, Lima, , Peru

Novartis Investigative Site, San Juan, , Puerto Rico

Novartis Investigative Site, Bratislava, , Slovakia

Novartis Investigative Site, Kosice, , Slovakia

Novartis Investigative Site, Martin, , Slovakia

Novartis Investigative Site, Parktown, Gauteng, South Africa

Novartis Investigative Site, Athlone Park, Amanzimtoti, , South Africa

Novartis Investigative Site, Port Elizabeth, , South Africa

Novartis Investigative Site, Saxonwold, Johannesburg, , South Africa

Novartis Investigative Site, Donetsk, , Ukraine

Novartis Investigative Site, Kyiv, , Ukraine

Novartis Investigative Site, Kyiv, , Ukraine

Novartis Investigative Site, Lviv, , Ukraine

Novartis Investigative Site, Makiivka, , Ukraine

Novartis Investigative Site, Simferopil, , Ukraine

Contact Details

Name: Novartis Pharmaceuticals

Affiliation: Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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