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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Treatment |
|
| B | No Intervention | Observation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | Rituximab 375mg/m2 i every 8 weeks for two years (12 infusions) |
|
| Measure | Description | Time Frame |
|---|---|---|
| event free survival | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival, overall survival and safety | four years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulrich Jaeger, Prof. Dr. | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Border Medical Oncology | Wodonga | Victoria | Australia | |||
| Concord Repatriation General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25911553 | Result | 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. | |
| 26521299 |
| Label | URL |
|---|---|
| AGMT | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Clinical Study Report | View IPD |
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| Concord |
| Australia |
| Gosford Hospital | Gosford | Australia |
| Greenslopes Hospital | Greenslopes | Australia |
| Prince of Wales Hospital | Sydney | Australia |
| Krankenhaus Oberpullendorf | Oberpullendorf | Burgenland | A-7350 | Austria |
| Krankenhaus Oberwart | Oberwart | Burgenland | A-7400 | Austria |
| A.ö. Krankenhaus der Landeshauptstadt St. Pölten | Sankt Pölten | Lower Austria | A-3100 | Austria |
| A.ö. Krankenhaus der Statutarstadt Wr. Neustadt | Wiener Neustadt | Lower Austria | A-2770 | Austria |
| St. Johanns LK | Salzburg | State of Salzburg | A-5020 | Austria |
| KH Barmherzige Brüder | Vienna | State of Vienna | A-1020 | Austria |
| Krankenhaus der Stadt Wien Rudolfsstiftung | Vienna | State of Vienna | A-1030 | Austria |
| AKH Wien / Hämatologie u. Hämostaseologie | Vienna | State of Vienna | A-1090 | Austria |
| Kaiser-Franz-Josef-Spital | Vienna | State of Vienna | A-1100 | Austria |
| Krankenhaus der Stadt Wien Lainz | Vienna | State of Vienna | A-1130 | Austria |
| Hanusch-Krankenhaus | Vienna | State of Vienna | A-1140 | Austria |
| Wilhelminenspital | Vienna | State of Vienna | A-1160 | Austria |
| Sozialmedizinisches Zentrum Ost - Donauspital | Vienna | State of Vienna | A-1220 | Austria |
| A.ö. Landeskrankenhaus Steyr | Steyr | Styria | A-4400 | Austria |
| Bezirkskrankenhaus Kufstein | Endach | Tyrol | A-6330 | Austria |
| A.oe.Bezirkskrankenhaus Hall | Hall in Tirol | Tyrol | A-6060 | Austria |
| Universitätsklinik Innsbruck/ Klinik für Innere Medizin | Innsbruck | Tyrol | A-6020 | Austria |
| Krankenhaus d. Barmherzigen Schwestern Linz | Linz | Upper Austria | A-4010 | Austria |
| Krankenhaus der Elisabethinen Linz | Linz | Upper Austria | A-4010 | Austria |
| KH Barmherzige Schwestern Ried | Ried | Upper Austria | A-4910 | Austria |
| Klinikum Kreuzschwestern Wels GmbH | Wels | Upper Austria | A-4600 | Austria |
| Landeskrankenhaus Feldkirch | Feldkirch | Vorarlberg | A-6806 | Austria |
| LKH Bregenz | Bregenz | A-6900 | Austria |
| KH Dornbirn | Dornbirn | A-6850 | Austria |
| A.ö. Landeskrankenhaus Fürstenfeld | Fürstenfeld | A-8280 | Austria |
| Universitätsklinikum Graz | Graz | A-8036 | Austria |
| LKH Hohenems | Hohenems | A-6845 | Austria |
| Universitaetsklinik Innsbruck | Innsbruck | A-6020 | Austria |
| Landeskrankenhaus Klagenfurt | Klagenfurt | A-9020 | Austria |
| A.ö. Landeskrankenhaus Leoben | Leoben | A-8700 | Austria |
| Krankenhaus der Stadt Linz | Linz | A-4020 | Austria |
| LKH Weinviertel Mistelbach | Mistelbach | A-2130 | Austria |
| LKH Villach | Villach | A-9500 | Austria |
| LKH Vöcklabruck | Vöcklabruck | A-4840 | Austria |
| KH Waidhofen/Thaya | Waidhofen an der Thaya | A-3830 | Austria |
| BKH Zams | Zams | A-6511 | Austria |
| Clinical Centre University Sarajevo | Sarajevo | 71 000 | Bosnia and Herzegovina |
| University Center Tuzla | Tuzla | 75000 | 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 | 12915 | Estonia |
| Tartu University Hospital | Tartu | 15014 | 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 | 22328 | 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 | 308007 | Russia |
| Moscow Regional Clinical Research Institute | Moscow | 115478 | Russia |
| Botkin City Clinical Hospital | Moscow | 125101 | Russia |
| Leningrad regional Cliniacal Hospital | Saint Petersburg | 194291 | Russia |
| SPB Pavlov State Medical University | Saint Petersburg | 197089 | Russia |
| Republican Clinic Oncology Dispensary | Ufa | 450054 | Russia |
| Novgorod Regional Clinical Hospital | Veliky Novgorod | 603126 | Russia |
| Clinical centre of Serbia | Belgrade | Belgrade | 11000 | Serbia |
| Institute of Oncology Sremska Kamenica | Kamenitz | 21204 | Serbia |
| Clinical Centre Nis | Niš | 18000 | Serbia |
| Clinical Centre Novi Sad | Novisad | 11000 | 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 | 1100 | Slovenia |
| Hopelands Cancer Centre | Pietremarizburg | South Africa |
| Wilgers Oncology Centre | Pretoria | South Africa |
| Falun Hospital | Falun | 79182 | Sweden |
| Sunderby Hospital | Luleå | 97180 | Sweden |
| Sundsvall Hospital | Sundsvall | 85186 | Sweden |
| Uddevalla Hospital | Uddevalla | 45180 | Sweden |
| Kaohsiung Medical University Hospital | Kaohsiung City | 807 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 112 | 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 | 06620 | Turkey (Türkiye) |
| Osmangazi Univ. school of Medicine | Eskişehir | 26480 | Turkey (Türkiye) |
| Gaziantep University School of Medicine | Gaziantep | 27310 | Turkey (Türkiye) |
| Ericyes Univ. Med. School | Kayseri | 38039 | Turkey (Türkiye) |
| Result |
| 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. |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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