A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation in Patients With Aggressive B-cell Lymphoma: NHL-13
NCT ID: NCT00400478
Last Updated: 2016-05-26
Study Results
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Basic Information
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COMPLETED
PHASE3
683 participants
INTERVENTIONAL
2006-01-31
2013-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Treatment
Rituximab
Rituximab 375mg/m2 i every 8 weeks for two years (12 infusions)
B
Observation
No interventions assigned to this group
Interventions
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Rituximab
Rituximab 375mg/m2 i every 8 weeks for two years (12 infusions)
Eligibility Criteria
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Inclusion Criteria
* 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
* Secondary malignancy
* Evidence of CNS - involvement
* Significant cardiac disease
* Creatinine \> 2.0 mg/dl
* HIV, Hepatitis positive
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Arbeitsgemeinschaft medikamentoese Tumortherapie
OTHER
Responsible Party
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Principal Investigators
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Ulrich Jaeger, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna
Locations
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Border Medical Oncology
Wodonga, Victoria, Australia
Concord Repatriation General Hospital
Concord, , Australia
Gosford Hospital
Gosford, , Australia
Greenslopes Hospital
Greenslopes, , Australia
Prince of Wales Hospital
Sydney, , Australia
Krankenhaus Oberpullendorf
Oberpullendorf, Burgenland, Austria
Krankenhaus Oberwart
Oberwart, Burgenland, Austria
A.ö. Krankenhaus der Landeshauptstadt St. Pölten
Sankt Pölten, Lower Austria, Austria
A.ö. Krankenhaus der Statutarstadt Wr. Neustadt
Wiener Neustadt, Lower Austria, Austria
St. Johanns LK
Salzburg, Salzburg, Austria
A.ö. Landeskrankenhaus Steyr
Steyr, Styria, Austria
Bezirkskrankenhaus Kufstein
Endach, Tyrol, Austria
A.oe.Bezirkskrankenhaus Hall
Hall in Tirol, Tyrol, Austria
Universitätsklinik Innsbruck/ Klinik für Innere Medizin
Innsbruck, Tyrol, Austria
Krankenhaus d. Barmherzigen Schwestern Linz
Linz, Upper Austria, Austria
Krankenhaus der Elisabethinen Linz
Linz, Upper Austria, Austria
KH Barmherzige Schwestern Ried
Ried, Upper Austria, Austria
Klinikum Kreuzschwestern Wels GmbH
Wels, Upper Austria, Austria
KH Barmherzige Brüder
Vienna, Vienna, Austria
Krankenhaus der Stadt Wien Rudolfsstiftung
Vienna, Vienna, Austria
AKH Wien / Hämatologie u. Hämostaseologie
Vienna, Vienna, Austria
Kaiser-Franz-Josef-Spital
Vienna, Vienna, Austria
Krankenhaus der Stadt Wien Lainz
Vienna, Vienna, Austria
Hanusch-Krankenhaus
Vienna, Vienna, Austria
Wilhelminenspital
Vienna, Vienna, Austria
Sozialmedizinisches Zentrum Ost - Donauspital
Vienna, Vienna, Austria
Landeskrankenhaus Feldkirch
Feldkirch, Vorarlberg, Austria
LKH Bregenz
Bregenz, , Austria
KH Dornbirn
Dornbirn, , Austria
A.ö. Landeskrankenhaus Fürstenfeld
Fürstenfeld, , 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
LKH Villach
Villach, , Austria
LKH Vöcklabruck
Vöcklabruck, , Austria
KH Waidhofen/Thaya
Waidhofen an der Thaya, , Austria
BKH Zams
Zams, , Austria
Clinical Centre University Sarajevo
Sarajevo, , Bosnia and Herzegovina
University Center Tuzla
Tuzla, , Bosnia and Herzegovina
Centro Goiano de Oncologia
Goiânia, , Brazil
Hospital Santa Izabel
Salvador, , Brazil
Hospital das Clinicas FMUSP
São Paulo, , Brazil
Hospital deas Clinical FMUSP
São Paulo, , 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
Beijing, , 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, , Czechia
Faculty Hospital Brno
Brno, , Czechia
Univ. Hospital and Med. School Hradec Kralove
Kralove, , Czechia
Onkologické Centrum J.G. Mendela
Novi Jicin, , Czechia
Fakultni Nemocnice Olomouc
Olomouc, , Czechia
Hospital Opava
Opava, , Czechia
Fakultni nemocnice Ostrava
Ostrava-Poruba, , Czechia
Charles University Hospital
Prague, , Czechia
Faculty Hospital Binohrady FNKV
Prague, , Czechia
University Hospital Motol
Prague, , Czechia
RTO MN Usti n. Labem
Ústí nad Labem, , Czechia
North Estonian Regional Hospital
Tallinn, , Estonia
Tartu University Hospital
Tartu, , Estonia
Queen Mary Hospital
Hong Kong, , Hong Kong
Tuen Mun Hospital
Hong Kong, , Hong Kong
Soroka Medical Centre
Beersheba, , Israel
Rambam Medical Centre
Haifa, , Israel
Rabin Medical Centre
Petah Tikva, , Israel
Kaplan Medical Centre
Rehovot, , Israel
Riga Hematology Center
Riga, , Latvia
Hospital Ampang
Ampang, , Malaysia
Hospital University Kebangsaan Malaysia
Kuala Lumpur, , Malaysia
ISSSTE Hospital Regional de Leon
León, , 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 City, , Mexico
Clinical Centre Skopje
Skopje, , North Macedonia
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
Târgu Mureş, , Romania
Emergency County Clinical Hospital
Târgu Mureş, , Romania
Belgorod regional Clinical Hospital
Belgorod, , Russia
Moscow Regional Clinical Research Institute
Moscow, , Russia
Botkin City Clinical Hospital
Moscow, , Russia
Leningrad regional Cliniacal Hospital
Saint Petersburg, , Russia
SPB Pavlov State Medical University
Saint Petersburg, , Russia
Republican Clinic Oncology Dispensary
Ufa, , Russia
Novgorod Regional Clinical Hospital
Veliky Novgorod, , Russia
Clinical centre of Serbia
Belgrade, Belgrade, Serbia
Institute of Oncology Sremska Kamenica
Kamenitz, , Serbia
Clinical Centre Nis
Niš, , Serbia
Clinical Centre Novi Sad
Novisad, , Serbia
National Cancer Institut Bratislava
Bratislava, , Slovakia
OUSA Bratislava
Bratislava, , Slovakia
Východoslovenský onkolgický ústav
Košice, , 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
Luleå, , Sweden
Sundsvall Hospital
Sundsvall, , Sweden
Uddevalla Hospital
Uddevalla, , Sweden
Kaohsiung Medical University Hospital
Kaohsiung City, , 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
Songkhla, , Thailand
Ankara University, School of Medicine
Ankara, , Turkey (Türkiye)
Osmangazi Univ. school of Medicine
Eskişehir, , Turkey (Türkiye)
Gaziantep University School of Medicine
Gaziantep, , Turkey (Türkiye)
Ericyes Univ. Med. School
Kayseri, , Turkey (Türkiye)
Countries
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References
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Jaeger U, Trneny M, Melzer H, Praxmarer M, Nawarawong W, Ben Yehuda D, Goldstein D, Mihaljevic B, Ilhan O, Ballova V, Hedenus M, Hsiao LT, Au WY, Burgstaller S, Weidinger G, Keil F, Dittrich C, Skrabs C, Klingler A, Chott A, Fridrik MA, Greil R; AGMT-NHL13 Investigators. Rituximab maintenance for patients with aggressive B-cell lymphoma in first remission: results of the randomized NHL13 trial. Haematologica. 2015 Jul;100(7):955-63. doi: 10.3324/haematol.2015.125344. Epub 2015 Apr 24.
Jaeger U, Praxmarer M, Greil R; AGMT-NHL13 investigators. Response to comment by P. Vassilakopoulos and colleagues. Haematologica. 2015 Nov;100(11):e482. doi: 10.3324/haematol.2015.134288. No abstract available.
Study Documents
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Document Type: Clinical Study Report
View DocumentRelated Links
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AGMT
Other Identifiers
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NHL-13 (ML18223)
Identifier Type: -
Identifier Source: org_study_id
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