Spots Global Cancer Trial Database for Rituximab Plus Lenalidomide for Patients With Relapsed / Refractory Indolent Non-Hodgkin's Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma)
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Trial Identification
Brief Title: Rituximab Plus Lenalidomide for Patients With Relapsed / Refractory Indolent Non-Hodgkin's Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma)
Official Title: A Phase 3, Double-blind, Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) Versus Rituximab Plus Placebo in Subjects With Relapsed/Refractory Indolent Lymphoma
Study ID: NCT01938001
Conditions
Study Description
Brief Summary: This double-blind randomized, parallel group study will evaluate the efficacy and safety of lenalidomide (Revlimid, CC-5013) in combination with rituximab (MabThera/Rituxan) in patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma. Patients will be randomized to receive either lenalidomide or placebo for twelve 28-day cycles in combination with rituximab. Anticipated time on study treatment is 1 year.
Detailed Description: Indolent lymphoma is a slow growing but incurable lymphoma which includes follicular lymphoma and marginal zone lymphoma. Follicular lymphoma and marginal zone lymphoma are cancers of the B lymphocyte, a type of white blood cell. Lenalidomide is an immunomodulatory drug (a drug that affects the immune system) which alters the body's immune system and it may also interfere with the development of tiny blood vessels involved in tumor growth. Therefore, lenalidomide may reduce or prevent the growth of cancer cells. Lenalidomide has also been shown to restore the immune cells' ability to attack and kill tumor cells, an ability that may be inhibited by follicular lymphoma and other lymphomas. The combination of rituximab and lenalidomide may eliminate the cancer while restoring the immune system's ability to attack tumor cells.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mitchell Cancer Center, University of South Alabama, Mobile, Alabama, United States
Arizona Center for Cancer Care, Glendale, Arizona, United States
Southwest Cancer Care Medical Group, Escondido, California, United States
Marin Oncology Associates, Greenbrae, California, United States
Wilshire Oncology Medical Group, Inc, La Verne, California, United States
North County Hematology Oncology (NCHO) - TRM, LLC., Oceanside, California, United States
Hematology-Oncology Medical Group of Orange County, Inc., Orange, California, United States
UC Davis Medical Center, Sacramento, California, United States
Central Coast Medical Oncology Corporation, Santa Maria, California, United States
Wellness Hematology Oncology, West Hills, California, United States
Cancer Center of Central Connecticut, Southington, Connecticut, United States
Florida Cancer Specialists North Region Sarah Cannon Research, Saint Petersburg, Florida, United States
Illinois Cancer Care, P.C., Peoria, Illinois, United States
LRG Healthcare Oncology Clinic, Laconia, Indiana, United States
Iowa Oncology Research Association, Des Moines, Iowa, United States
University of Louisville, J.G. Brown Cancer Center, Louisville, Kentucky, United States
Providence Cancer Institute, Southfield, Michigan, United States
Mayo Clinic, Rochester, Minnesota, United States
Coborn Cancer Center at the St. Cloud Hospital, Saint Cloud, Minnesota, United States
NH Oncology - Hematology, PA, Hooksett, New Hampshire, United States
The Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
Hematology-Oncology Associates of Northern NJ, Morristown, New Jersey, United States
University of New Mexico, Albuquerque, New Mexico, United States
Weill Cornell Medical College, New York, New York, United States
SUNY Upstate Medical University, Syracuse, New York, United States
Wake Forest Baptist Health, Winston-Salem, North Carolina, United States
Oncology Hematology Care Sarah Cannon Research, Cincinnati, Ohio, United States
Local Institution - 028, Portland, Oregon, United States
Providence Portland Medical Center, Portland, Oregon, United States
St Francis Hospital, Greenville, South Carolina, United States
Spartanburg Regional Healthcare System - Gibbs Cancer Center & Research Institute, Spartanburg, South Carolina, United States
Sarah Cannon Research Inst, Nashville, Tennessee, United States
Arlington Cancer Center, Arlington, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Northwest Medical Specialties PLLC, Tacoma, Washington, United States
AZ St-Jan Brugge Oostende AV, Brugge, , Belgium
Local Institution - 371, Gent, , Belgium
UZ Gent, Gent, , Belgium
AZ Groeninge, Kortrijk, , Belgium
CHU Mont -Godinne, Yvoir, , Belgium
Associacao Hospitalar Moinhos de Vento Hospital Moinhos de Vento, Porto Alegre, Rio Grande Do Sul, Brazil
Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande Do Sul, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS, Porto Alegre, Rio Grande Do Sul, Brazil
Associacao Educudora Sao Carlos AESC Hospital Giovanni Battista HGB Hospital Mae de Deus Center, Porto Alegre, Rio Grande Do Sul, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos, Barretos, São Paulo, Brazil
Hospital Dr. Amaral Carvalho/ Hospital Amaral Carvalho Jaú, Jau/SP, São Paulo, Brazil
MS INCA HC I Hospital do Cancer I, Rio De Janeiro, , Brazil
Sociedade Beneficente de Senhoras Hospital Sirio Libanes, São Paulo, , Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia, São Paulo, , Brazil
Fundação Antonio Prudente - AC Camargo Câncer center, São Paulo, , Brazil
Beijing Cancer Hospital, Beijing, PR, , China
Peking University People's Hospital, Beijing, , China
307 Hospital of PLA, Beijing, , China
Peking Union Medical College Hospital, Beijing, , China
The Third Xiangya hospital of central south university, Changsha, , China
West China Hospital of Sichuan University, Chengdu, , China
Fujian Medical University Union Hospital, Fuzhou, , China
Sun Yat-sen University Cancer Center, Guangzhou, , China
Guangdong General Hospital, Guangzhou, , China
Local Institution - 600, Guangzhou, , China
The First Affiliated Hospital of Medical School of Zhejiang University, Hangzhou City, , China
Local Institution - 604, Hangzhou City, , China
Jiangsu Province Hospital The First Hospital affiliated with Nanjing Medical University, Nanjing, , China
Cancer Hospital, Fudan University, Shanghai, , China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, , China
The First Affiliated Hospital of Soochow University, Suzhou, , China
Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, , China
Tianjin Medical University Cancer Institute and Hospital, Tianjin, , China
Xijing Hospital, Xi'an, , China
Interni hematoonkologicka klinika, Brno, , Czechia
Fakultni nemocnice Hradec Kralove, IV.interni hematologicka klinika, Hradec Kralove, , Czechia
Fakultni Nemocnice Ostrava, Klinika hematoonkologie,, Ostrava, , Czechia
Fakultni nemocnice Kralovske Vinohrady, Interni hematologicka klinika, Prague 10, , Czechia
Local Institution - 534, Praha, , Czechia
Vseobecna Fakultni Nemocnice v Praze, Praha, , Czechia
CHU d'Angers, Angers, , France
Centre Hospitalier Universitaire d'Avicennes, Bobigny Cedex, , France
CHRU de Brest - Hopital Morvan, Brest Cedex, , France
Hopital Saint-Louis, Paris, , France
CH Perpignan - Hopital Saint-Jean, Perpignan, , France
CHU de Poitiers, Poitiers, , France
Centre Hospitalier de Valence, Valence, , France
Charite - Universitaetsmedizin Berlin Charité - Campus Benjamin Franklin, Berlin, , Germany
Charite - Universitaetsmedizin Berlin Campus Virchow Klinikum, Berlin, , Germany
Krankenhaus Nordwest, Frankfurt, , Germany
Onkologische Schwerpunktpraxis Leer - Emden, Leer, , Germany
Kliniken Maria Hilf GmbH, Mönchengladbach, , Germany
Klinkum der Stadt Villingen-Schwenningen GmbH, Villingen-Schwenningen, , Germany
Soroka University Medical Center, Beer Sheva, , Israel
Hadassah University Hospital, Jerusalem, , Israel
Tel-Aviv Sourasky Medical Center, Tel-Aviv, , Israel
Centro di Riferimento Oncologico - IRCCS, Aviano (PN), , Italy
U.O.C. Ematologia, Barletta, , Italy
A.O.U. di Bologna Policlinico S.Orsola-Malpighi, Bologna, , Italy
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi - Nesima, Catania, , Italy
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.), Meldola, , Italy
Istituto Europeo di Oncologia - IEO, Milano, , Italy
Ospedale Niguarda Ca Granda, Milano, , Italy
IRCCS- Istituto Nazionale per lo Studio e la Cura dei Tumori, Fondazione "G. Pascale", Napoli, , Italy
Az. Osp. Vincenzo Cervello, Palermo, , Italy
Casa di Cura La Maddalena, Palermo, , Italy
Azienda Ospedaliero-Universitaria di Parma, Parma, , Italy
Ospedale di Ravenna, Ravenna, , Italy
Azienda Ospedaliera Bianchi-Melacrino-Morelli, Reggio Calabria, , Italy
Ospedale degli Infermi di Rimini, Rimini, , Italy
Azienda Ospedaliera S. Andrea - Università La Sapienza, Roma, , Italy
Local Institution - 340, Roma, , Italy
Local Institution - 708, Nagasaki-shi, Nagasaki, Japan
Local Institution - 709, Minato-ku, Tokyo, Japan
National Cancer Center Hospital, Chuo-ku, , Japan
Chugoku Central Hospital, Hiroshima, , Japan
National Cancer Center Hospital East, Kashiwa, , Japan
Kobe City Medical Center General Hospital, Kobe-city, , Japan
The Cancer Institute Hospital of Japanese Foundation For Cancer Research, Koto-ku, , Japan
Local Institution - 700, Koto-ku, , Japan
University Hospital, Kyoto Prefectural University of Medicine, Kyoto-city, , Japan
Toranomon Hospital, Minato-ku, , Japan
The Japanese Red Cross Nagasaki Genbaku Hospital, Nagasaki, , Japan
Nagoya Medical Center,Division of Hematology/Oncology, Nagoya, , Japan
National University Corporation Tohoku University, Tohoku University Hospital, Sendai-shi, , Japan
Malopolskie Centrum Medyczne S.C., Kraków, , Poland
Instytut Hematologii i Transfuzjologii w Warszawie, Warszawa, , Poland
Local Institution - 514, Warszawa, , Poland
Centrum Onkologii, Instytut im. Marii Sklodowskiej-Curie, Warszawa, , Poland
Local Institution - 513, Warszawa, , Poland
Instituto Portugues de Oncologia de Lisboa, Francisco Gentil, Lisboa, , Portugal
Local Institution - 330, Lisboa, , Portugal
Instituto Portugues de Oncologia do Porto, Francisco Gentil, Porto, , Portugal
Local Institution - 331, Porto, , Portugal
Hospital Auxilio Muto Centro de Cancer, San Juan, , Puerto Rico
Krasnoyarsk Regional Clinical Hospital, Krasnoyarsk, , Russian Federation
Russian Academy of Medical Sciences Institution, Moscow, , Russian Federation
Moscow State Medical Institution Municipal Clinical Hospital n.a. S.P. Botkin, Moscow, , Russian Federation
Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov, St Petersburg, , Russian Federation
St. Petersburg Pavlov State Medical University, St.Petersburg, , Russian Federation
The Ministry of Health and Social Development of the Tula region state institution Health Tula regio, Tula, , Russian Federation
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Universitario Reina Sofia, Córdoba, , Spain
Local Institution - 314, Córdoba, , Spain
Hospital Universitario Infanta Leonor, Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Costa del Sol, Marbella, , Spain
Local Institution - 315, Marbella, , Spain
Hospital Morales Meseguer, Murcia, , Spain
Local Institution - 318, Murcia, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Local Institution - 311, Salamanca, , Spain
Hospital Universitario Virgen Del Rocio, Sevilla, , Spain
Cukurova University Medical Faculty Balcali Hospital, Adana, , Turkey
Hacettepe Universitesi, Ankara, , Turkey
Pamukkale University Medical Faculty, Denizli, , Turkey
Gaziantep University, Gaziantep, , Turkey
Marmara University, Istanbul, , Turkey
Dokuz Eylul University Izmir, Izmir, , Turkey
19 Mayis Medical Faculty - Samsun, Samsun, , Turkey
Kocaeli Derince Training and Research Hospital, Umuttepe Kocaeli, , Turkey
Eastbourne District General Hospital, Eastbourne, , United Kingdom
Royal Liverpool University Hospital, Prescot Street, Liverpool, , United Kingdom
Barts Cancer Institute, Queen Mary University of London, Charterhouse Square, London, , United Kingdom
Southend University Hospital NHS Foundation Trust, Prittlewell Chase, Westcliff on Sea, , United Kingdom
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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