Spots Global Cancer Trial Database for A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation in Patients With Aggressive B-cell Lymphoma: NHL-13
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Trial Identification
Brief Title: A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation in Patients With Aggressive B-cell Lymphoma: NHL-13
Official Title: A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation Alone in Patients With Aggressive B-cell Lymphoma: NHL-13
Study ID: NCT00400478
Interventions
Study Description
Brief Summary: This is a randomized, open label, phase III study to evaluate the ability of rituximab maintenance therapy to prolong event-free survival in aggressive NHL. Patients will be screened after successful standard induction therapy (CR or Cru following standard R-CHOP-like therapy with 8 infusions of rituximab plus CHOP-like chemotherapy (4-8 cycles). Patients will be followed until an event occurs as defined in the protocol. To evaluate the clinical efficacy of rituximab maintenance therapy as compared to observation in patients with aggressive B-cell Non-Hodgkins lymphoma or follicular lymphoma grade 3b who have achieved a complete remission after appropriate first-line therapy, measured by event-free survival (EFS), 440 patients with DLCBL or follicular NHL grade 3 (220 per arm) will be recruited.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Border Medical Oncology, Wodonga, Victoria, Australia
Concord Repatriation General Hospital, Concord, , Australia
Gosford Hospital, Gosford, , Australia
Greenslopes Hospital, Greenslopes, , Australia
Prince of Wales Hospital, Sidney, , Australia
Krankenhaus Oberpullendorf, Oberpullendorf, Burgenland, Austria
Krankenhaus Oberwart, Oberwart, Burgenland, Austria
A.ö. Krankenhaus der Landeshauptstadt St. Pölten, St. Poelten, Niederoesterreich, Austria
A.ö. Krankenhaus der Statutarstadt Wr. Neustadt, Wr. Neustadt, Niederoesterreich, Austria
Krankenhaus d. Barmherzigen Schwestern Linz, Linz, Oberoesterreich, Austria
Krankenhaus der Elisabethinen Linz, Linz, Oberoesterreich, Austria
KH Barmherzige Schwestern Ried, Ried, Oberoesterreich, Austria
Klinikum Kreuzschwestern Wels GmbH, Wels, Oberösterreich, Austria
A.ö. Landeskrankenhaus Steyr, Steyr, Steiermark, Austria
Bezirkskrankenhaus Kufstein, Endach, Tirol, Austria
A.oe.Bezirkskrankenhaus Hall, Hall, Tirol, Austria
Universitätsklinik Innsbruck/ Klinik für Innere Medizin, Innsbruck, Tirol, Austria
Landeskrankenhaus Feldkirch, Feldkirch, Vorarlberg, Austria
LKH Bregenz, Bregenz, , Austria
KH Dornbirn, Dornbirn, , Austria
A.ö. Landeskrankenhaus Fürstenfeld, Fuerstenfeld, , Austria
Universitätsklinikum Graz, Graz, , Austria
LKH Hohenems, Hohenems, , Austria
Universitaetsklinik Innsbruck, Innsbruck, , Austria
Landeskrankenhaus Klagenfurt, Klagenfurt, , Austria
A.ö. Landeskrankenhaus Leoben, Leoben, , Austria
Krankenhaus der Stadt Linz, Linz, , Austria
LKH Weinviertel Mistelbach, Mistelbach, , Austria
St. Johanns LK, Salzburg, , Austria
KH Barmherzige Brüder, Vienna, , Austria
Krankenhaus der Stadt Wien Rudolfsstiftung, Vienna, , Austria
AKH Wien / Hämatologie u. Hämostaseologie, Vienna, , Austria
Kaiser-Franz-Josef-Spital, Vienna, , Austria
Krankenhaus der Stadt Wien Lainz, Vienna, , Austria
Hanusch-Krankenhaus, Vienna, , Austria
Wilhelminenspital, Vienna, , Austria
Sozialmedizinisches Zentrum Ost - Donauspital, Vienna, , Austria
LKH Villach, Villach, , Austria
LKH Vöcklabruck, Voecklabruck, , Austria
KH Waidhofen/Thaya, Waidhofen, , Austria
BKH Zams, Zams, , Austria
Clinical Centre University Sarajevo, Sarajevo, , Bosnia and Herzegovina
University Center Tuzla, Tuzla, , Bosnia and Herzegovina
Centro Goiano de Oncologia, Goiania, , Brazil
Hospital Santa Izabel, Salvador, , Brazil
Hospital das Clinicas FMUSP, Sao Paolo, , Brazil
Hospital deas Clinical FMUSP, Sao Paolo, , Brazil
UMHAT "St. George" Plodviv, Plovdiv, , Bulgaria
Nat. Centre of Hematology and Transfusiology Sofia, Sofia, , Bulgaria
MHAT "St. Marina" Varna, Varna, , Bulgaria
Chinese PLA General hospital, Bejing, , China
West China Hospital of Sichuan University, Chengdu, , China
Harbin Institue, Harbin, , China
Jiangsu Cancer Hospital, Nanjing, , China
Changhai Hospital, Shanghai, , China
Shanghai Ruijin Hospital, Shanghai, , China
Clinical Hopital Center Zagreb, Zagreb, , Croatia
Clinical Hospital Dubrava, Zagreb, , Croatia
Clinicall Hospital "Merkur", Zagreb, , Croatia
Nemocnice Boskovice s.r.o., Boskovice, , Czech Republic
Faculty Hospital Brno, Brno, , Czech Republic
Univ. Hospital and Med. School Hradec Kralove, Kralove, , Czech Republic
Onkologické Centrum J.G. Mendela, Novi Jicin, , Czech Republic
Fakultni Nemocnice Olomouc, Olomouc, , Czech Republic
Hospital Opava, Opava, , Czech Republic
Fakultni nemocnice Ostrava, Ostrava-Poruba, , Czech Republic
Faculty Hospital Binohrady FNKV, Prague, , Czech Republic
Charles University Hospital, Praha, , Czech Republic
University Hospital Motol, Praha, , Czech Republic
RTO MN Usti n. Labem, Usti nad Labem, , Czech Republic
North Estonian Regional Hospital, Tallin, , Estonia
Tartu University Hospital, Tartu, , Estonia
Queen Mary Hospital, Hong Kong, , Hong Kong
Tuen Mun Hospital, Hong Kong, , Hong Kong
Soroka Medical Centre, Beer Sheva, , Israel
Rambam Medical Centre, Haifa, , Israel
Rabin Medical Centre, Petah-Tikva, , Israel
Kaplan Medical Centre, Rehovot, , Israel
Riga Hematology Center, Riga, , Latvia
Clinical Centre Skopje, Skopje, , Macedonia, The Former Yugoslav Republic of
Hospital Ampang, Ampang, , Malaysia
Hospital University Kebangsaan Malaysia, Kuala Lumpur, , Malaysia
ISSSTE Hospital Regional de Leon, Leon, , Mexico
Hospital Espanol de Mexico, Mexico City, , Mexico
Hospital General de Mexico, Mexico City, , Mexico
Instituto National de Cancerologia, Mexico City, , Mexico
Hospital Regional Monterrey, ISSTE, Monterrey, , Mexico
ISSSTEP Puebla, Puebla, , Mexico
Hospital Carlso alberto seguin escobedo Arequipa, Arequipa, , Peru
Hospital Alberto Sabogal sooguren Callao, Callao, , Peru
Coltea Hospital, Bucharest, , Romania
Coltea Hospital, Bucharest, , Romania
University Emergency Center Bucharest, Bucharest, , Romania
Clinic Judatean de Urgenta Brasov, Targu Mures, , Romania
Emergency County Clinical Hospital, Targu Mures, , Romania
Belgorod regional Clinical Hospital, Belgorod, , Russian Federation
Moscow Regional Clinical Research Institute, Moscow, , Russian Federation
Botkin City Clinical Hospital, Moscow, , Russian Federation
Novgorod Regional Clinical Hospital, Novgorod, , Russian Federation
Leningrad regional Cliniacal Hospital, St. Petersburg, , Russian Federation
SPB Pavlov State Medical University, St. Petersburg, , Russian Federation
Republican Clinic Oncology Dispensary, Ufa, , Russian Federation
Clinical centre of Serbia, Belgrade, , Serbia
Clinical Centre Nis, NIs, , Serbia
Clinical Centre Novi Sad, Novisad, , Serbia
Institute of Oncology Sremska Kamenica, Sremska Kamenica, , Serbia
National Cancer Institut Bratislava, Bratislava, , Slovakia
OUSA Bratislava, Bratislava, , Slovakia
Východoslovenský onkolgický ústav, Kosice, , Slovakia
Martinská fakultná nemocnima, Martin, , Slovakia
Institut of Oncology Ljubljana, Ljubljana, , Slovenia
Hopelands Cancer Centre, Pietremarizburg, , South Africa
Wilgers Oncology Centre, Pretoria, , South Africa
Falun Hospital, Falun, , Sweden
Sunderby Hospital, Lulea, , Sweden
Sundsvall Hospital, Sundsvall, , Sweden
Uddevalla Hospital, Uddevalla, , Sweden
Kaohsiung Medical University Hospital, Kaohsiung, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Taichung Veterans General Hospital, Taipei, , Taiwan
King Chulalongkorn Memorial Hospital, Bangkok, , Thailand
Phramongkutklao College of Medicine, Bangkok, , Thailand
Ramathibodi Hospital, Bangkok, , Thailand
Siriray Hospital, Bangkok, , Thailand
Chiang Mai University, Chiang Mai, , Thailand
Srinagarind Hospital, Khon kaen, , Thailand
Songklanagrarind Hospital, Songkla, , Thailand
Ankara University, School of Medicine, Ankara, , Turkey
Osmangazi Univ. school of Medicine, Eskisehir, , Turkey
Gaziantep University School of Medicine, Gaziantep, , Turkey
Ericyes Univ. Med. School, Kayseri, , Turkey
Contact Details
Name: Ulrich Jaeger, Prof. Dr.
Affiliation: Medical University of Vienna
Role: PRINCIPAL_INVESTIGATOR
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