A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation in Patients With Aggressive B-cell Lymphoma: NHL-13

PHASE3CompletedINTERVENTIONAL
Enrollment

683

Participants

Timeline

Start Date

January 31, 2006

Primary Completion Date

March 31, 2013

Study Completion Date

March 31, 2013

Conditions
Diffuse Large B-Cell Lymphoma (DLBCL)Follicular NHL Grade 3b
Interventions
DRUG

Rituximab

Rituximab 375mg/m2 i every 8 weeks for two years (12 infusions)

Trial Locations (131)

112

Taipei Veterans General Hospital, Taipei

807

Kaohsiung Medical University Hospital, Kaohsiung City

1100

Institut of Oncology Ljubljana, Ljubljana

11000

Clinical centre of Serbia, Belgrade

Clinical Centre Novi Sad, Novisad

12915

North Estonian Regional Hospital, Tallinn

15014

Tartu University Hospital, Tartu

18000

Clinical Centre Nis, Niš

21204

Institute of Oncology Sremska Kamenica, Kamenitz

22328

Coltea Hospital, Bucharest

26480

Osmangazi Univ. school of Medicine, Eskişehir

27310

Gaziantep University School of Medicine, Gaziantep

38039

Ericyes Univ. Med. School, Kayseri

45180

Uddevalla Hospital, Uddevalla

75000

University Center Tuzla, Tuzla

79182

Falun Hospital, Falun

85186

Sundsvall Hospital, Sundsvall

97180

Sunderby Hospital, Luleå

115478

Moscow Regional Clinical Research Institute, Moscow

125101

Botkin City Clinical Hospital, Moscow

194291

Leningrad regional Cliniacal Hospital, Saint Petersburg

197089

SPB Pavlov State Medical University, Saint Petersburg

308007

Belgorod regional Clinical Hospital, Belgorod

450054

Republican Clinic Oncology Dispensary, Ufa

603126

Novgorod Regional Clinical Hospital, Veliky Novgorod

Unknown

Border Medical Oncology, Wodonga

Concord Repatriation General Hospital, Concord

Gosford Hospital, Gosford

Greenslopes Hospital, Greenslopes

Prince of Wales Hospital, Sydney

Centro Goiano de Oncologia, Goiânia

Hospital Santa Izabel, Salvador

Hospital das Clinicas FMUSP, São Paulo

Hospital deas Clinical FMUSP, São Paulo

"UMHAT St. George Plodviv", Plovdiv

Nat. Centre of Hematology and Transfusiology Sofia, Sofia

"MHAT St. Marina Varna", Varna

Chinese PLA General hospital, Beijing

West China Hospital of Sichuan University, Chengdu

Harbin Institue, Harbin

Jiangsu Cancer Hospital, Nanjing

Changhai Hospital, Shanghai

Shanghai Ruijin Hospital, Shanghai

Clinical Hopital Center Zagreb, Zagreb

Clinical Hospital Dubrava, Zagreb

"Clinicall Hospital Merkur", Zagreb

Nemocnice Boskovice s.r.o., Boskovice

Faculty Hospital Brno, Brno

Univ. Hospital and Med. School Hradec Kralove, Kralove

Onkologické Centrum J.G. Mendela, Novi Jicin

Fakultni Nemocnice Olomouc, Olomouc

Hospital Opava, Opava

Fakultni nemocnice Ostrava, Ostrava-Poruba

Charles University Hospital, Prague

Faculty Hospital Binohrady FNKV, Prague

University Hospital Motol, Prague

RTO MN Usti n. Labem, Ústí nad Labem

Queen Mary Hospital, Hong Kong

Tuen Mun Hospital, Hong Kong

Soroka Medical Centre, Beersheba

Rambam Medical Centre, Haifa

Rabin Medical Centre, Petah Tikva

Kaplan Medical Centre, Rehovot

Riga Hematology Center, Riga

Hospital Ampang, Ampang

Hospital University Kebangsaan Malaysia, Kuala Lumpur

ISSSTE Hospital Regional de Leon, León

Hospital Espanol de Mexico, Mexico City

Hospital General de Mexico, Mexico City

Instituto National de Cancerologia, Mexico City

Hospital Regional Monterrey, ISSTE, Monterrey

ISSSTEP Puebla, Puebla City

Clinical Centre Skopje, Skopje

Hospital Carlso alberto seguin escobedo Arequipa, Arequipa

Hospital Alberto Sabogal sooguren Callao, Callao

Coltea Hospital, Bucharest

University Emergency Center Bucharest, Bucharest

Clinic Judatean de Urgenta Brasov, Târgu Mureş

Emergency County Clinical Hospital, Târgu Mureş

National Cancer Institut Bratislava, Bratislava

OUSA Bratislava, Bratislava

Východoslovenský onkolgický ústav, Košice

Martinská fakultná nemocnima, Martin

Hopelands Cancer Centre, Pietremarizburg

Wilgers Oncology Centre, Pretoria

Taichung Veterans General Hospital, Taipei

King Chulalongkorn Memorial Hospital, Bangkok

Phramongkutklao College of Medicine, Bangkok

Ramathibodi Hospital, Bangkok

Siriray Hospital, Bangkok

Chiang Mai University, Chiang Mai

Srinagarind Hospital, Khon Kaen

Songklanagrarind Hospital, Songkhla

A-7350

Krankenhaus Oberpullendorf, Oberpullendorf

A-7400

Krankenhaus Oberwart, Oberwart

A-3100

A.ö. Krankenhaus der Landeshauptstadt St. Pölten, Sankt Pölten

A-2770

A.ö. Krankenhaus der Statutarstadt Wr. Neustadt, Wiener Neustadt

A-5020

St. Johanns LK, Salzburg

A-4400

A.ö. Landeskrankenhaus Steyr, Steyr

A-6330

Bezirkskrankenhaus Kufstein, Endach

A-6060

A.oe.Bezirkskrankenhaus Hall, Hall in Tirol

A-6020

Universitätsklinik Innsbruck/ Klinik für Innere Medizin, Innsbruck

Universitaetsklinik Innsbruck, Innsbruck

A-4010

Krankenhaus d. Barmherzigen Schwestern Linz, Linz

Krankenhaus der Elisabethinen Linz, Linz

A-4910

KH Barmherzige Schwestern Ried, Ried

A-4600

Klinikum Kreuzschwestern Wels GmbH, Wels

A-1020

KH Barmherzige Brüder, Vienna

A-1030

Krankenhaus der Stadt Wien Rudolfsstiftung, Vienna

A-1090

AKH Wien / Hämatologie u. Hämostaseologie, Vienna

A-1100

Kaiser-Franz-Josef-Spital, Vienna

A-1130

Krankenhaus der Stadt Wien Lainz, Vienna

A-1140

Hanusch-Krankenhaus, Vienna

A-1160

Wilhelminenspital, Vienna

A-1220

Sozialmedizinisches Zentrum Ost - Donauspital, Vienna

A-6806

Landeskrankenhaus Feldkirch, Feldkirch

A-6900

LKH Bregenz, Bregenz

A-6850

KH Dornbirn, Dornbirn

A-8280

A.ö. Landeskrankenhaus Fürstenfeld, Fürstenfeld

A-8036

Universitätsklinikum Graz, Graz

A-6845

LKH Hohenems, Hohenems

A-9020

Landeskrankenhaus Klagenfurt, Klagenfurt

A-8700

A.ö. Landeskrankenhaus Leoben, Leoben

A-4020

Krankenhaus der Stadt Linz, Linz

A-2130

LKH Weinviertel Mistelbach, Mistelbach

A-9500

LKH Villach, Villach

A-4840

LKH Vöcklabruck, Vöcklabruck

A-3830

KH Waidhofen/Thaya, Waidhofen an der Thaya

A-6511

BKH Zams, Zams

71 000

Clinical Centre University Sarajevo, Sarajevo

06620

Ankara University, School of Medicine, Ankara

All Listed Sponsors
collaborator

Hoffmann-La Roche

INDUSTRY

lead

Arbeitsgemeinschaft medikamentoese Tumortherapie

OTHER

NCT00400478 - A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation in Patients With Aggressive B-cell Lymphoma: NHL-13 | Biotech Hunter | Biotech Hunter