Clinical trial NCT00400478: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diffuse Large B-Cell Lymphoma (DLBCL)
Follicular NHL Grade 3b
Keywords: DLBCL
NHL 13
Rituximab
maintenance
Lead sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2006-11-17
Enrollment: 683
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: event free survival
timeFrame: 4 years
Secondary outcomes:
measure: progression free survival, overall survival and safety
timeFrame: four years
Other outcomes:
Locations:
city: Wodonga
country: Australia
facility: Border Medical Oncology
state: Victoria
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
city: Gosford
country: Australia
facility: Gosford Hospital
city: Greenslopes
country: Australia
facility: Greenslopes Hospital
city: Sidney
country: Australia
facility: Prince of Wales Hospital
city: Oberpullendorf
country: Austria
facility: Krankenhaus Oberpullendorf
state: Burgenland
city: Oberwart
country: Austria
facility: Krankenhaus Oberwart
state: Burgenland
city: St. Poelten
country: Austria
facility: A.ö. Krankenhaus der Landeshauptstadt St. Pölten
state: Niederoesterreich
city: Wr. Neustadt
country: Austria
facility: A.ö. Krankenhaus der Statutarstadt Wr. Neustadt
state: Niederoesterreich
city: Linz
country: Austria
facility: Krankenhaus d. Barmherzigen Schwestern Linz
state: Oberoesterreich
city: Linz
country: Austria
facility: Krankenhaus der Elisabethinen Linz
state: Oberoesterreich
city: Ried
country: Austria
facility: KH Barmherzige Schwestern Ried
state: Oberoesterreich
city: Wels
country: Austria
facility: Klinikum Kreuzschwestern Wels GmbH
state: Oberösterreich
city: Steyr
country: Austria
facility: A.ö. Landeskrankenhaus Steyr
state: Steiermark
city: Endach
country: Austria
facility: Bezirkskrankenhaus Kufstein
state: Tirol
city: Hall
country: Austria
facility: A.oe.Bezirkskrankenhaus Hall
state: Tirol
city: Innsbruck
country: Austria
facility: Universitätsklinik Innsbruck/ Klinik für Innere Medizin
state: Tirol
city: Feldkirch
country: Austria
facility: Landeskrankenhaus Feldkirch
state: Vorarlberg
city: Bregenz
country: Austria
facility: LKH Bregenz
city: Dornbirn
country: Austria
facility: KH Dornbirn
city: Fuerstenfeld
country: Austria
facility: A.ö. Landeskrankenhaus Fürstenfeld
city: Graz
country: Austria
facility: Universitätsklinikum Graz
city: Hohenems
country: Austria
facility: LKH Hohenems
city: Innsbruck
country: Austria
facility: Universitaetsklinik Innsbruck
city: Klagenfurt
country: Austria
facility: Landeskrankenhaus Klagenfurt
city: Leoben
country: Austria
facility: A.ö. Landeskrankenhaus Leoben
city: Linz
country: Austria
facility: Krankenhaus der Stadt Linz
city: Mistelbach
country: Austria
facility: LKH Weinviertel Mistelbach
city: Salzburg
country: Austria
facility: St. Johanns LK
city: Vienna
country: Austria
facility: KH Barmherzige Brüder
city: Vienna
country: Austria
facility: Krankenhaus der Stadt Wien Rudolfsstiftung
city: Vienna
country: Austria
facility: AKH Wien / Hämatologie u. Hämostaseologie
city: Vienna
country: Austria
facility: Kaiser-Franz-Josef-Spital
city: Vienna
country: Austria
facility: Krankenhaus der Stadt Wien Lainz
city: Vienna
country: Austria
facility: Hanusch-Krankenhaus
city: Vienna
country: Austria
facility: Wilhelminenspital
city: Vienna
country: Austria
facility: Sozialmedizinisches Zentrum Ost - Donauspital
city: Villach
country: Austria
facility: LKH Villach
city: Voecklabruck
country: Austria
facility: LKH Vöcklabruck
city: Waidhofen
country: Austria
facility: KH Waidhofen/Thaya
city: Zams
country: Austria
facility: BKH Zams
city: Sarajevo
country: Bosnia and Herzegovina
facility: Clinical Centre University Sarajevo
city: Tuzla
country: Bosnia and Herzegovina
facility: University Center Tuzla
city: Goiania
country: Brazil
facility: Centro Goiano de Oncologia
city: Salvador
country: Brazil
facility: Hospital Santa Izabel
city: Sao Paolo
country: Brazil
facility: Hospital das Clinicas FMUSP
city: Sao Paolo
country: Brazil
facility: Hospital deas Clinical FMUSP
city: Plovdiv
country: Bulgaria
facility: UMHAT "St. George" Plodviv
city: Sofia
country: Bulgaria
facility: Nat. Centre of Hematology and Transfusiology Sofia
city: Varna
country: Bulgaria
facility: MHAT "St. Marina" Varna
city: Bejing
country: China
facility: Chinese PLA General hospital
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
city: Harbin
country: China
facility: Harbin Institue
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
city: Shanghai
country: China
facility: Changhai Hospital
city: Shanghai
country: China
facility: Shanghai Ruijin Hospital
city: Zagreb
country: Croatia
facility: Clinical Hopital Center Zagreb
city: Zagreb
country: Croatia
facility: Clinical Hospital Dubrava
city: Zagreb
country: Croatia
facility: Clinicall Hospital "Merkur"
city: Boskovice
country: Czech Republic
facility: Nemocnice Boskovice s.r.o.
city: Brno
country: Czech Republic
facility: Faculty Hospital Brno
city: Kralove
country: Czech Republic
facility: Univ. Hospital and Med. School Hradec Kralove
city: Novi Jicin
country: Czech Republic
facility: Onkologické Centrum J.G. Mendela
city: Olomouc
country: Czech Republic
facility: Fakultni Nemocnice Olomouc
city: Opava
country: Czech Republic
facility: Hospital Opava
city: Ostrava-Poruba
country: Czech Republic
facility: Fakultni nemocnice Ostrava
city: Prague
country: Czech Republic
facility: Faculty Hospital Binohrady FNKV
city: Praha
country: Czech Republic
facility: Charles University Hospital
city: Praha
country: Czech Republic
facility: University Hospital Motol
city: Usti nad Labem
country: Czech Republic
facility: RTO MN Usti n. Labem
city: Tallin
country: Estonia
facility: North Estonian Regional Hospital
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Hong Kong
country: Hong Kong
facility: Tuen Mun Hospital
city: Beer Sheva
country: Israel
facility: Soroka Medical Centre
city: Haifa
country: Israel
facility: Rambam Medical Centre
city: Petah-Tikva
country: Israel
facility: Rabin Medical Centre
city: Rehovot
country: Israel
facility: Kaplan Medical Centre
city: Riga
country: Latvia
facility: Riga Hematology Center
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
facility: Clinical Centre Skopje
city: Ampang
country: Malaysia
facility: Hospital Ampang
city: Kuala Lumpur
country: Malaysia
facility: Hospital University Kebangsaan Malaysia
city: Leon
country: Mexico
facility: ISSSTE Hospital Regional de Leon
city: Mexico City
country: Mexico
facility: Hospital Espanol de Mexico
city: Mexico City
country: Mexico
facility: Hospital General de Mexico
city: Mexico City
country: Mexico
facility: Instituto National de Cancerologia
city: Monterrey
country: Mexico
facility: Hospital Regional Monterrey, ISSTE
city: Puebla
country: Mexico
facility: ISSSTEP Puebla
city: Arequipa
country: Peru
facility: Hospital Carlso alberto seguin escobedo Arequipa
city: Callao
country: Peru
facility: Hospital Alberto Sabogal sooguren Callao
city: Bucharest
country: Romania
facility: Coltea Hospital
city: Bucharest
country: Romania
facility: Coltea Hospital
city: Bucharest
country: Romania
facility: University Emergency Center Bucharest
city: Targu Mures
country: Romania
facility: Clinic Judatean de Urgenta Brasov
city: Targu Mures
country: Romania
facility: Emergency County Clinical Hospital
city: Belgorod
country: Russian Federation
facility: Belgorod regional Clinical Hospital
city: Moscow
country: Russian Federation
facility: Moscow Regional Clinical Research Institute
city: Moscow
country: Russian Federation
facility: Botkin City Clinical Hospital
city: Novgorod
country: Russian Federation
facility: Novgorod Regional Clinical Hospital
city: St. Petersburg
country: Russian Federation
facility: Leningrad regional Cliniacal Hospital
city: St. Petersburg
country: Russian Federation
facility: SPB Pavlov State Medical University
city: Ufa
country: Russian Federation
facility: Republican Clinic Oncology Dispensary
city: Belgrade
country: Serbia
facility: Clinical centre of Serbia
city: NIs
country: Serbia
facility: Clinical Centre Nis
city: Novisad
country: Serbia
facility: Clinical Centre Novi Sad
city: Sremska Kamenica
country: Serbia
facility: Institute of Oncology Sremska Kamenica
city: Bratislava
country: Slovakia
facility: National Cancer Institut Bratislava
city: Bratislava
country: Slovakia
facility: OUSA Bratislava
city: Kosice
country: Slovakia
facility: Východoslovenský onkolgický ústav
city: Martin
country: Slovakia
facility: Martinská fakultná nemocnima
city: Ljubljana
country: Slovenia
facility: Institut of Oncology Ljubljana
city: Pietremarizburg
country: South Africa
facility: Hopelands Cancer Centre
city: Pretoria
country: South Africa
facility: Wilgers Oncology Centre
city: Falun
country: Sweden
facility: Falun Hospital
city: Lulea
country: Sweden
facility: Sunderby Hospital
city: Sundsvall
country: Sweden
facility: Sundsvall Hospital
city: Uddevalla
country: Sweden
facility: Uddevalla Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Taichung Veterans General Hospital
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Bangkok
country: Thailand
facility: Phramongkutklao College of Medicine
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Bangkok
country: Thailand
facility: Siriray Hospital
city: Chiang Mai
country: Thailand
facility: Chiang Mai University
city: Khon kaen
country: Thailand
facility: Srinagarind Hospital
city: Songkla
country: Thailand
facility: Songklanagrarind Hospital
city: Ankara
country: Turkey
facility: Ankara University, School of Medicine
city: Eskisehir
country: Turkey
facility: Osmangazi Univ. school of Medicine
city: Gaziantep
country: Turkey
facility: Gaziantep University School of Medicine
city: Kayseri
country: Turkey
facility: Ericyes Univ. Med. School
Study officials:
affiliation: Medical University of Vienna
name: Ulrich Jaeger, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.