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

Condition(s) targeted: Diffuse Large B-Cell Lymphoma (DLBCL); Follicular NHL Grade 3b

Intervention: Rituximab (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Arbeitsgemeinschaft medikamentoese Tumortherapie

Official(s) and/or principal investigator(s):
Ulrich Jaeger, Prof. Dr., Principal Investigator, Affiliation: Medical University of Vienna

Overall contact:
ulrich jaeger, prof dr, Phone: +43 1 40400, Ext: 4410, Email: ulrich.jaeger@meduniwien.ac.at

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.

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 design: Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study

Primary outcome: Event-free survival

Secondary outcome: progression free survival

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

ulrich jaeger, prof dr, Phone: +43 1 40400, Ext: 4410, Email: ulrich.jaeger@meduniwien.ac.at

A.ö. Landeskrankenhaus Leoben, Leoben 8700, Austria; Recruiting
Felix Keil, Prpf. Dr.

A.ö. Landeskrankenhaus Fürstenfeld, fuerstenfeld 8280, Austria; Recruiting
Heinz Seewann, Prof. Dr

Universitätsklinikum Graz, graz 8036, Austria; Recruiting
Gerald jaeger, Prof. Dr.

Landeskrankenhaus Klagenfurt, Klagenfurt 9020, Austria; Recruiting
Dietmar Geissler, Prof. Dr.

Sozialmedizinisches Zentrum Ost - Donauspital, Vienna 1220, Austria; Recruiting
Reinhard Ruckser, Dr.

Wilhelminenspital, Vienna 1160, Austria; Recruiting
Heinz Ludwig, Univ.Prof.Dr

Krankenhaus der Stadt Linz, Linz 4020, Austria; Recruiting
Michael Fridrik, Prof. Dr.

KH Bamherzige Schwestern Ried, Ried 4910, Austria; Recruiting
Friedrich Renner, Prof. Dr.
Friedrich Renner, Prof. Dr, Principal Investigator

KH Waidhofen/Thaya, Waidhofen 3830, Austria; Recruiting
Andreas Kretschmer, Dr

LKH Weinviertel Mistelbach, Mistelbach 2130, Austria; Recruiting
Christoph Wiltschke, Prof

LKH Villach, Villach 9500, Austria; Recruiting
Rudolf Foditsch, Dr
Rudolf Foditsch, Dr., Principal Investigator

LKH Vöcklabruck, Voecklabruck 4840, Austria; Recruiting
Lothar Schiller
Lothar Schiller, Dr, Principal Investigator

KH Dornbirn, Dornbirn 6850, Austria; Recruiting
Burkhard Walla
Burkhard Walla, Dr, Principal Investigator

LKH Bregenz, Bregenz 6900, Austria; Recruiting
Franz Xaver Schmid
Franz Xaver Schmid, Dr, Principal Investigator

UNIVKlinik Innsbruck, Innsbruck 6020, Austria; Recruiting
Wolfgang Eisterer, Prof, Principal Investigator

BKH Zams, Zams 6511, Austria; Recruiting
Ewald Woell
Ewald Wöll, Prof, Principal Investigator

LKH Hohenems, Hohenems 6845, Austria; Recruiting
Gerhard Mathis
Gebhard Mathis, Prof. Dr., Principal Investigator

Krankenhaus d. bamherzigen Schwestern Linz, Linz 4010, Austria; Recruiting
Andreas Petzer, Prof. Dr

St. Johanns LK, Salzburg 5020, Austria; Recruiting
Richard Greil, Prof. Dr.

Krankenhaus der stadt Wien Lainz, Vienna 1130, Austria; Recruiting
Klaus Geissler, Prof. Dr.

Kaiser-Franz-Josef-Spital, Vienna 1100, Austria; Recruiting
Christian Dittrich, Prof.Dr.

Krankenhaus der Stadt Wien Rudolfsstifung, Vienna 1030, Austria; Recruiting
Monika Wirt, Dr.

Hanusch-Krankenhaus, Vienna 1140, Austria; Recruiting
Georg Hopfinger, Dr

KH Bamherzige Brüder, Vienna 1020, Austria; Recruiting
Johannes Meran, Prof. Dr.

AKH Wien / Hämatologie u. Hämostaseologie, vienna 1090, Austria; Recruiting
ulrich jaeger, Prof. Dr., Phone: +43 1 40400, Ext: 4410, Email: ulrich.jaeger@meduniwien.ac.at
ulrich jaeger, Prof.Dr, Principal Investigator

Clinical Centre University Sarajevo, Sarajevo 71 000, Bosnia and Herzegovina; Recruiting
Sabira Kurtovic, Dr.

University Center Tuzla, Tuzla 75000, Bosnia and Herzegovina; Recruiting
Milomir Malesevic, DR

Tartu University Hospital, Tartu 15014, Estonia; Recruiting
Hele Everaus, Dr., Principal Investigator

North Estonian Regional Hospital, Tallin 12915, Estonia; Recruiting
Iige Viigimaa, Dr., Principal Investigator

Queen Mary Hospital, Hong Kong, Hong Kong; Recruiting
Raymond Liang, Dr

Tuen Mun Hospital, Hong Kong, Hong Kong; Recruiting
yu-Ming Yeung, Dr.

Hospital Alberto Sabogal sooguren Callao, Callao, Peru; Recruiting
Manuel Philco Salas, Dr, Principal Investigator

Hospital Carlso alberto seguin escobedo Arequipa, Arequipa, Peru; Recruiting
Mariella haydee Fuentes, Dr., Principal Investigator

Coltea Hospital, Bucharest, Romania; Recruiting
Anca Lupu, Dr.

Emergency County Clinical Hospitall, Targu Mures, Romania; Recruiting
Galafteon Oltean, Dr.

University Emergency Center Bucharest, Bucharest, Romania; Recruiting
Ana Vladaneanu, Dr.

Clinic Judatean de Urgenta Brasov, Targu Mures, Romania; Recruiting
Istvan Benedak, Dr.

Coltea Hospital, Bucharest 22328, Romania; Recruiting
Coriu Daniel, Dr, Principal Investigator

Moscow Regional Clinical Research Institute, Moscow 115478, Russian Federation; Recruiting
Irina Poddubnaya, Dr., Principal Investigator

Leningrad regional Cliniacal Hospital, St. Petersburg 194291, Russian Federation; Recruiting
Tatjana Schneyder, Dr, Principal Investigator

Botkin City Clinical Hospital, Moscow 125101, Russian Federation; Recruiting
Valentina Ivanova, Dr, Principal Investigator

SPB Pavlov State Medical University, St. Petersburg 197089, Russian Federation; Recruiting
Boris Afanasiev, Dr, Principal Investigator

Republican Clinic Oncology Dispensary, Ufa 450054, Russian Federation; Recruiting
Oleg Lipatov, Dr, Principal Investigator

Novgorod Regional Clinical Hospital, Novgorod 603126, Russian Federation; Recruiting
Olga Samoylova, Dr, Principal Investigator

Belgorod regional Clinical Hospital, Belgorod 308007, Russian Federation; Recruiting
Ludmilla Melvedeva, Dr., Principal Investigator

Clinical Centre Novi Sad, Novi Sad 11000, Serbia and Montenegro; Recruiting
Ivanka Savic, Dr

Institute of Ocology Sremska Kamenica, Sremska Kamenica 21204, Serbia and Montenegro; Recruiting
Darjana Jovanovic, Dr.

Clinical Centre Nis, NIs 18000, Serbia and Montenegro; Recruiting
Nenad Govedarevic

Clinical centre of Serbia, Belgrade 11000, Serbia and Montenegro; Recruiting
Biljana Mihaljevic, Dr

Institut of Oncology Ljubljana, Ljubljana 1100, Slovenia; Recruiting
Jezersek, Dr., Principal Investigator

Sunderby Hospital, Lulea 97180, Sweden; Recruiting
Brigitta Lauri, Dr., Principal Investigator

Sundsvall Hospital, Sundsvall 85186, Sweden; Recruiting
Michael Hedenus, Dr, Principal Investigator

Uddevalla Hospital, Uddevalla 45180, Sweden; Recruiting
Olof lindqvist, Dr., Principal Investigator

Falun Hospital, Falun 79182, Sweden; Recruiting
Kristina Wallman, Dr., Principal Investigator

Taichung Veterans General Hospital, Taipei, Taiwan; Recruiting
Ji-Hsiung Young, Dr.

Kaohsiung Medical University Hospital, Kaohsiung 807, Taiwan; Recruiting
Sheng-Fung Lin, Dr.

Taipei Veterans General Hospital, Taipei 112, Taiwan; Recruiting
Liang-tsai Hsiao, Dr.

Ankara University, School of Medicine, Ankara 06620, Turkey; Recruiting
Osman Ilhan, Dr, Principal Investigator

Ericyes Univ. Med. School, Kayseri 38039, Turkey; Recruiting
Mustafa Cetin, Prof, Principal Investigator

Gaziantep University School of Medicine, Gaziantep 27310, Turkey; Recruiting
Mehmet Yimaz, Prof. Dr., Principal Investigator

Osmangazi Univ. school of Medicine, Eskisehir 26480, Turkey; Recruiting
Zafer Gülbas, Prof. Dr, Principal Investigator

Krankenhaus Oberwart, Oberwart, Burgenland 7400, Austria; Recruiting
Wolfgang Stangl, Dr

Krankenhaus Oberpullendorf, Oberpullendorf, Burgenland 7350, Austria; Recruiting
Felix Stockenhuber, Prof.Dr

A.ö. Krankenhaus der Landeshauptstadt St. Pölten, St. Poelten, NOE 3100, Austria; Recruiting
Peter Balcke, Prof. Dr

A.ö. Krankenhaus der Statutarstadt Wr. Neustadt, Wr. Neustadt, Noe 2770, Austria; Recruiting
Herwig Niessner, Prof. Dr.

A.ö. Landeskrankenhaus Steyr, Steyr, Styria 4400, Austria; Recruiting
Richard Haidinger, Prim. Dr.

Universitätsklinik Innsbruck/ Klinik für Innere Medizin, Innsbruck, Tirol 6020, Austria; Recruiting
Eberhard Gunsilius, Prof.Dr

A.oe.Bezirkskrankenhaus Hall, Hall, Tirol 6060, Austria; Recruiting
Herbert Tilg, Prof. Dr.

Bezirkskrankenhaus Kufstein, Endach, Tirol 6330, Austria; Recruiting
Klaus Gattinger, Prof. Dr.

Landeskrankenhaus Feldkirch, Feldkirch, Tirol 6806, Austria; Recruiting
Alois Lang, Dr.

Krankenhaus der Elisabethinen Linz, Linz, Upper Austria 4010, Austria; Recruiting
Dieter Lutz, Prof.Dr.

Klinikum Kreuzschwestern Wels GmbH, wels, oberösterreich A-4600, Austria; Recruiting
josef thaler, Prof.Dr
josef thaler, Prof.Dr, Principal Investigator

Starting date: January 2006
Ending date: December 2012
Last updated: November 2, 2007