A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation in Patients With Aggressive B-cell Lymphoma: NHL-13
- Conditions
- Diffuse Large B-Cell Lymphoma (DLBCL)Follicular NHL Grade 3b
- Interventions
- Registration Number
- NCT00400478
- Lead Sponsor
- Arbeitsgemeinschaft medikamentoese Tumortherapie
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 683
- 4 to 8 cycles R-CHOP/like, total of 8x Rituximab
- CR, CRu
- ECOG/ 0.1 or 2
- Known IPI at time of diagnosis
- Age > 18 years
- Negative pregnancy test
- Men must agree not to father a child during the therapy
- Transformed lymphoma
- Secondary malignancy
- Evidence of CNS - involvement
- Significant cardiac disease
- Creatinine > 2.0 mg/dl
- HIV, Hepatitis positive
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Rituximab Treatment
- Primary Outcome Measures
Name Time Method event free survival 4 years
- Secondary Outcome Measures
Name Time Method progression free survival, overall survival and safety four years
Trial Locations
- Locations (130)
LKH Weinviertel Mistelbach
🇦🇹Mistelbach, Austria
LKH Villach
🇦🇹Villach, Austria
LKH Vöcklabruck
🇦🇹Voecklabruck, Austria
OUSA Bratislava
🇸🇰Bratislava, Slovakia
Concord Repatriation General Hospital
🇦🇺Concord, Australia
Prince of Wales Hospital
🇦🇺Sidney, Australia
MHAT "St. Marina" Varna
🇧🇬Varna, Bulgaria
Greenslopes Hospital
🇦🇺Greenslopes, Australia
Kaplan Medical Centre
🇮🇱Rehovot, Israel
UMHAT "St. George" Plodviv
🇧🇬Plovdiv, Bulgaria
Novgorod Regional Clinical Hospital
🇷🇺Novgorod, Russian Federation
Belgorod regional Clinical Hospital
🇷🇺Belgorod, Russian Federation
SPB Pavlov State Medical University
🇷🇺St. Petersburg, Russian Federation
Hospital deas Clinical FMUSP
🇧🇷Sao Paolo, Brazil
Krankenhaus der Stadt Wien Rudolfsstiftung
🇦🇹Vienna, Austria
Faculty Hospital Binohrady FNKV
🇨🇿Prague, Czech Republic
Chinese PLA General hospital
🇨🇳Bejing, China
Nat. Centre of Hematology and Transfusiology Sofia
🇧🇬Sofia, Bulgaria
Centro Goiano de Oncologia
🇧🇷Goiania, Brazil
Clinical Hospital Dubrava
🇭🇷Zagreb, Croatia
Clinicall Hospital "Merkur"
🇭🇷Zagreb, Croatia
Soroka Medical Centre
🇮🇱Beer Sheva, Israel
Hospital Santa Izabel
🇧🇷Salvador, Brazil
Wilgers Oncology Centre
🇿🇦Pretoria, South Africa
Hospital das Clinicas FMUSP
🇧🇷Sao Paolo, Brazil
Onkologické Centrum J.G. Mendela
🇨🇿Novi Jicin, Czech Republic
Hospital Ampang
🇲🇾Ampang, Malaysia
Clinical Hopital Center Zagreb
🇭🇷Zagreb, Croatia
Falun Hospital
🇸🇪Falun, Sweden
Sunderby Hospital
🇸🇪Lulea, Sweden
Moscow Regional Clinical Research Institute
🇷🇺Moscow, Russian Federation
Rambam Medical Centre
🇮🇱Haifa, Israel
Clinical Centre Skopje
🇲🇰Skopje, Macedonia, The Former Yugoslav Republic of
Rabin Medical Centre
🇮🇱Petah-Tikva, Israel
Republican Clinic Oncology Dispensary
🇷🇺Ufa, Russian Federation
Botkin City Clinical Hospital
🇷🇺Moscow, Russian Federation
Institut of Oncology Ljubljana
🇸🇮Ljubljana, Slovenia
Uddevalla Hospital
🇸🇪Uddevalla, Sweden
Ericyes Univ. Med. School
🇹🇷Kayseri, Turkey
Hopelands Cancer Centre
🇿🇦Pietremarizburg, South Africa
Sundsvall Hospital
🇸🇪Sundsvall, Sweden
Osmangazi Univ. school of Medicine
🇹🇷Eskisehir, Turkey
Ankara University, School of Medicine
🇹🇷Ankara, Turkey
Phramongkutklao College of Medicine
🇹🇭Bangkok, Thailand
Gaziantep University School of Medicine
🇹🇷Gaziantep, Turkey
Krankenhaus d. Barmherzigen Schwestern Linz
🇦🇹Linz, Oberoesterreich, Austria
Klinikum Kreuzschwestern Wels GmbH
🇦🇹Wels, Oberösterreich, Austria
Bezirkskrankenhaus Kufstein
🇦🇹Endach, Tirol, Austria
KH Dornbirn
🇦🇹Dornbirn, Austria
St. Johanns LK
🇦🇹Salzburg, Austria
University Center Tuzla
🇧🇦Tuzla, Bosnia and Herzegovina
Hospital Opava
🇨🇿Opava, Czech Republic
Charles University Hospital
🇨🇿Praha, Czech Republic
RTO MN Usti n. Labem
🇨🇿Usti nad Labem, Czech Republic
Tartu University Hospital
🇪🇪Tartu, Estonia
ISSSTEP Puebla
🇲🇽Puebla, Mexico
Hospital Alberto Sabogal sooguren Callao
🇵🇪Callao, Peru
Emergency County Clinical Hospital
🇷🇴Targu Mures, Romania
Clinical Centre Nis
🇷🇸NIs, Serbia
KH Barmherzige Schwestern Ried
🇦🇹Ried, Oberoesterreich, Austria
LKH Bregenz
🇦🇹Bregenz, Austria
LKH Hohenems
🇦🇹Hohenems, Austria
Universitaetsklinik Innsbruck
🇦🇹Innsbruck, Austria
Krankenhaus der Stadt Linz
🇦🇹Linz, Austria
Clinical Centre University Sarajevo
🇧🇦Sarajevo, Bosnia and Herzegovina
University Hospital Motol
🇨🇿Praha, Czech Republic
Hospital University Kebangsaan Malaysia
🇲🇾Kuala Lumpur, Malaysia
ISSSTE Hospital Regional de Leon
🇲🇽Leon, Mexico
Hospital General de Mexico
🇲🇽Mexico City, Mexico
Clinical Centre Novi Sad
🇷🇸Novisad, Serbia
Srinagarind Hospital
🇹🇭Khon kaen, Thailand
Songklanagrarind Hospital
🇹🇭Songkla, Thailand
KH Barmherzige Brüder
🇦🇹Vienna, Austria
A.ö. Krankenhaus der Statutarstadt Wr. Neustadt
🇦🇹Wr. Neustadt, Niederoesterreich, Austria
Krankenhaus der Elisabethinen Linz
🇦🇹Linz, Oberoesterreich, Austria
A.ö. Landeskrankenhaus Steyr
🇦🇹Steyr, Steiermark, Austria
A.oe.Bezirkskrankenhaus Hall
🇦🇹Hall, Tirol, Austria
A.ö. Landeskrankenhaus Fürstenfeld
🇦🇹Fuerstenfeld, 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
KH Waidhofen/Thaya
🇦🇹Waidhofen, Austria
BKH Zams
🇦🇹Zams, Austria
Faculty Hospital Brno
🇨🇿Brno, Czech Republic
Hospital Regional Monterrey, ISSTE
🇲🇽Monterrey, Mexico
King Chulalongkorn Memorial Hospital
🇹🇭Bangkok, Thailand
A.ö. Krankenhaus der Landeshauptstadt St. Pölten
🇦🇹St. Poelten, Niederoesterreich, Austria
Landeskrankenhaus Feldkirch
🇦🇹Feldkirch, Vorarlberg, Austria
Krankenhaus Oberpullendorf
🇦🇹Oberpullendorf, Burgenland, Austria
Landeskrankenhaus Klagenfurt
🇦🇹Klagenfurt, Austria
A.ö. Landeskrankenhaus Leoben
🇦🇹Leoben, Austria
Univ. Hospital and Med. School Hradec Kralove
🇨🇿Kralove, Czech Republic
Fakultni nemocnice Ostrava
🇨🇿Ostrava-Poruba, Czech Republic
North Estonian Regional Hospital
🇪🇪Tallin, Estonia
Instituto National de Cancerologia
🇲🇽Mexico City, Mexico
Coltea Hospital
🇷🇴Bucharest, Romania
Universitätsklinikum Graz
🇦🇹Graz, Austria
Sozialmedizinisches Zentrum Ost - Donauspital
🇦🇹Vienna, Austria
Riga Hematology Center
🇱🇻Riga, Latvia
Hospital Espanol de Mexico
🇲🇽Mexico City, Mexico
Hospital Carlso alberto seguin escobedo Arequipa
🇵🇪Arequipa, Peru
University Emergency Center Bucharest
🇷🇴Bucharest, Romania
Clinic Judatean de Urgenta Brasov
🇷🇴Targu Mures, Romania
Clinical centre of Serbia
🇷🇸Belgrade, Serbia
Východoslovenský onkolgický ústav
🇸🇰Kosice, Slovakia
Martinská fakultná nemocnima
🇸🇰Martin, Slovakia
Siriray Hospital
🇹🇭Bangkok, Thailand
Taichung Veterans General Hospital
🇨🇳Taipei, Taiwan
Institute of Oncology Sremska Kamenica
🇷🇸Sremska Kamenica, Serbia
Kaohsiung Medical University Hospital
🇨🇳Kaohsiung, Taiwan
Ramathibodi Hospital
🇹🇭Bangkok, Thailand
Chiang Mai University
🇹🇭Chiang Mai, Thailand
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
West China Hospital of Sichuan University
🇨🇳Chengdu, China
Harbin Institue
🇨🇳Harbin, China
Changhai Hospital
🇨🇳Shanghai, China
Shanghai Ruijin Hospital
🇨🇳Shanghai, China
Jiangsu Cancer Hospital
🇨🇳Nanjing, China
Border Medical Oncology
🇦🇺Wodonga, Victoria, Australia
Gosford Hospital
🇦🇺Gosford, Australia
Krankenhaus Oberwart
🇦🇹Oberwart, Burgenland, Austria
Universitätsklinik Innsbruck/ Klinik für Innere Medizin
🇦🇹Innsbruck, Tirol, Austria
Fakultni Nemocnice Olomouc
🇨🇿Olomouc, Czech Republic
Nemocnice Boskovice s.r.o.
🇨🇿Boskovice, Czech Republic
Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong
Leningrad regional Cliniacal Hospital
🇷🇺St. Petersburg, Russian Federation
National Cancer Institut Bratislava
🇸🇰Bratislava, Slovakia
Tuen Mun Hospital
🇭🇰Hong Kong, Hong Kong