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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00400478
Recruitment Status : Completed
First Posted : November 17, 2006
Last Update Posted : May 26, 2016
Hoffmann-La Roche
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diffuse Large B-Cell Lymphoma (DLBCL) Follicular NHL Grade 3b Drug: Rituximab Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 683 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2006
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arm Intervention/treatment
Active Comparator: A
Drug: Rituximab
Rituximab 375mg/m2 i every 8 weeks for two years (12 infusions)

No Intervention: B

Primary Outcome Measures :
  1. event free survival [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. progression free survival, overall survival and safety [ Time Frame: four years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Transformed lymphoma
  • Secondary malignancy
  • Evidence of CNS - involvement
  • Significant cardiac disease
  • Creatinine > 2.0 mg/dl
  • HIV, Hepatitis positive

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00400478

  Hide Study Locations
Australia, Victoria
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, A-7350
Krankenhaus Oberwart
Oberwart, Burgenland, Austria, A-7400
A.ö. Krankenhaus der Landeshauptstadt St. Pölten
St. Poelten, Niederoesterreich, Austria, A-3100
A.ö. Krankenhaus der Statutarstadt Wr. Neustadt
Wr. Neustadt, Niederoesterreich, Austria, A-2770
Krankenhaus d. Barmherzigen Schwestern Linz
Linz, Oberoesterreich, Austria, A-4010
Krankenhaus der Elisabethinen Linz
Linz, Oberoesterreich, Austria, A-4010
KH Barmherzige Schwestern Ried
Ried, Oberoesterreich, Austria, A-4910
Klinikum Kreuzschwestern Wels GmbH
Wels, Oberösterreich, Austria, A-4600
A.ö. Landeskrankenhaus Steyr
Steyr, Steiermark, Austria, A-4400
Bezirkskrankenhaus Kufstein
Endach, Tirol, Austria, A-6330
A.oe.Bezirkskrankenhaus Hall
Hall, Tirol, Austria, A-6060
Universitätsklinik Innsbruck/ Klinik für Innere Medizin
Innsbruck, Tirol, Austria, A-6020
Landeskrankenhaus Feldkirch
Feldkirch, Vorarlberg, Austria, A-6806
LKH Bregenz
Bregenz, Austria, A-6900
KH Dornbirn
Dornbirn, Austria, A-6850
A.ö. Landeskrankenhaus Fürstenfeld
Fuerstenfeld, Austria, A-8280
Universitätsklinikum Graz
Graz, Austria, A-8036
LKH Hohenems
Hohenems, Austria, A-6845
Universitaetsklinik Innsbruck
Innsbruck, Austria, A-6020
Landeskrankenhaus Klagenfurt
Klagenfurt, Austria, A-9020
A.ö. Landeskrankenhaus Leoben
Leoben, Austria, A-8700
Krankenhaus der Stadt Linz
Linz, Austria, A-4020
LKH Weinviertel Mistelbach
Mistelbach, Austria, A-2130
St. Johanns LK
Salzburg, Austria, A-5020
KH Barmherzige Brüder
Vienna, Austria, A-1020
Krankenhaus der Stadt Wien Rudolfsstiftung
Vienna, Austria, A-1030
AKH Wien / Hämatologie u. Hämostaseologie
Vienna, Austria, A-1090
Vienna, Austria, A-1100
Krankenhaus der Stadt Wien Lainz
Vienna, Austria, A-1130
Vienna, Austria, A-1140
Vienna, Austria, A-1160
Sozialmedizinisches Zentrum Ost - Donauspital
Vienna, Austria, A-1220
LKH Villach
Villach, Austria, A-9500
LKH Vöcklabruck
Voecklabruck, Austria, A-4840
KH Waidhofen/Thaya
Waidhofen, Austria, A-3830
BKH Zams
Zams, Austria, A-6511
Bosnia and Herzegovina
Clinical Centre University Sarajevo
Sarajevo, Bosnia and Herzegovina, 71 000
University Center Tuzla
Tuzla, Bosnia and Herzegovina, 75000
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
Czech Republic
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, 12915
Tartu University Hospital
Tartu, Estonia, 15014
Hong Kong
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
Macedonia, The Former Yugoslav Republic of
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
Puebla, Mexico
Hospital Carlso alberto seguin escobedo Arequipa
Arequipa, Peru
Hospital Alberto Sabogal sooguren Callao
Callao, Peru
Coltea Hospital
Bucharest, Romania, 22328
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
Russian Federation
Belgorod regional Clinical Hospital
Belgorod, Russian Federation, 308007
Moscow Regional Clinical Research Institute
Moscow, Russian Federation, 115478
Botkin City Clinical Hospital
Moscow, Russian Federation, 125101
Novgorod Regional Clinical Hospital
Novgorod, Russian Federation, 603126
Leningrad regional Cliniacal Hospital
St. Petersburg, Russian Federation, 194291
SPB Pavlov State Medical University
St. Petersburg, Russian Federation, 197089
Republican Clinic Oncology Dispensary
Ufa, Russian Federation, 450054
Clinical centre of Serbia
Belgrade, Serbia, 11000
Clinical Centre Nis
NIs, Serbia, 18000
Clinical Centre Novi Sad
Novisad, Serbia, 11000
Institute of Oncology Sremska Kamenica
Sremska Kamenica, Serbia, 21204
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, 1100
South Africa
Hopelands Cancer Centre
Pietremarizburg, South Africa
Wilgers Oncology Centre
Pretoria, South Africa
Falun Hospital
Falun, Sweden, 79182
Sunderby Hospital
Lulea, Sweden, 97180
Sundsvall Hospital
Sundsvall, Sweden, 85186
Uddevalla Hospital
Uddevalla, Sweden, 45180
Kaohsiung Medical University Hospital
Kaohsiung, Taiwan, 807
Taipei Veterans General Hospital
Taipei, Taiwan, 112
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, 06620
Osmangazi Univ. school of Medicine
Eskisehir, Turkey, 26480
Gaziantep University School of Medicine
Gaziantep, Turkey, 27310
Ericyes Univ. Med. School
Kayseri, Turkey, 38039
Sponsors and Collaborators
Arbeitsgemeinschaft medikamentoese Tumortherapie
Hoffmann-La Roche
Principal Investigator: Ulrich Jaeger, Prof. Dr. Medical University of Vienna

Additional Information:
AGMT  This link exits the site

Study Data/Documents: Clinical Study Report  This link exits the site

Publications of Results:
Responsible Party: Arbeitsgemeinschaft medikamentoese Tumortherapie Identifier: NCT00400478     History of Changes
Other Study ID Numbers: NHL-13 (ML18223)
First Posted: November 17, 2006    Key Record Dates
Last Update Posted: May 26, 2016
Last Verified: May 2016

Keywords provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:
NHL 13

Additional relevant MeSH terms:
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents