Diffuse Large B-Cell Lymphoma (DLBCL) Clinical Trial
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
| Verified date | May 2016 |
| Source | Arbeitsgemeinschaft medikamentoese Tumortherapie |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Austria: Ethikkommission |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 683 |
| Est. completion date | March 2013 |
| Est. primary completion date | March 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | Concord Repatriation General Hospital | Concord | |
| Australia | Gosford Hospital | Gosford | |
| Australia | Greenslopes Hospital | Greenslopes | |
| Australia | Prince of Wales Hospital | Sidney | |
| Australia | Border Medical Oncology | Wodonga | Victoria |
| Austria | LKH Bregenz | Bregenz | |
| Austria | KH Dornbirn | Dornbirn | |
| Austria | Bezirkskrankenhaus Kufstein | Endach | Tirol |
| Austria | Landeskrankenhaus Feldkirch | Feldkirch | Vorarlberg |
| Austria | A.ö. Landeskrankenhaus Fürstenfeld | Fuerstenfeld | |
| Austria | Universitätsklinikum Graz | Graz | |
| Austria | A.oe.Bezirkskrankenhaus Hall | Hall | Tirol |
| Austria | LKH Hohenems | Hohenems | |
| Austria | Universitaetsklinik Innsbruck | Innsbruck | |
| Austria | Universitätsklinik Innsbruck/ Klinik für Innere Medizin | Innsbruck | Tirol |
| Austria | Landeskrankenhaus Klagenfurt | Klagenfurt | |
| Austria | A.ö. Landeskrankenhaus Leoben | Leoben | |
| Austria | Krankenhaus d. Barmherzigen Schwestern Linz | Linz | Oberoesterreich |
| Austria | Krankenhaus der Elisabethinen Linz | Linz | Oberoesterreich |
| Austria | Krankenhaus der Stadt Linz | Linz | |
| Austria | LKH Weinviertel Mistelbach | Mistelbach | |
| Austria | Krankenhaus Oberpullendorf | Oberpullendorf | Burgenland |
| Austria | Krankenhaus Oberwart | Oberwart | Burgenland |
| Austria | KH Barmherzige Schwestern Ried | Ried | Oberoesterreich |
| Austria | St. Johanns LK | Salzburg | |
| Austria | A.ö. Krankenhaus der Landeshauptstadt St. Pölten | St. Poelten | Niederoesterreich |
| Austria | A.ö. Landeskrankenhaus Steyr | Steyr | Steiermark |
| Austria | AKH Wien / Hämatologie u. Hämostaseologie | Vienna | |
| Austria | Hanusch-Krankenhaus | Vienna | |
| Austria | Kaiser-Franz-Josef-Spital | Vienna | |
| Austria | KH Barmherzige Brüder | Vienna | |
| Austria | Krankenhaus der Stadt Wien Lainz | Vienna | |
| Austria | Krankenhaus der Stadt Wien Rudolfsstiftung | Vienna | |
| Austria | Sozialmedizinisches Zentrum Ost - Donauspital | Vienna | |
| Austria | Wilhelminenspital | Vienna | |
| Austria | LKH Villach | Villach | |
| Austria | LKH Vöcklabruck | Voecklabruck | |
| Austria | KH Waidhofen/Thaya | Waidhofen | |
| Austria | Klinikum Kreuzschwestern Wels GmbH | Wels | Oberösterreich |
| Austria | A.ö. Krankenhaus der Statutarstadt Wr. Neustadt | Wr. Neustadt | Niederoesterreich |
| Austria | BKH Zams | Zams | |
| Bosnia and Herzegovina | Clinical Centre University Sarajevo | Sarajevo | |
| Bosnia and Herzegovina | University Center Tuzla | Tuzla | |
| Brazil | Centro Goiano de Oncologia | Goiania | |
| Brazil | Hospital Santa Izabel | Salvador | |
| Brazil | Hospital das Clinicas FMUSP | Sao Paolo | |
| Brazil | Hospital deas Clinical FMUSP | Sao Paolo | |
| Bulgaria | UMHAT "St. George" Plodviv | Plovdiv | |
| Bulgaria | Nat. Centre of Hematology and Transfusiology Sofia | Sofia | |
| Bulgaria | MHAT "St. Marina" Varna | Varna | |
| China | 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 | |
| Croatia | Clinical Hopital Center Zagreb | Zagreb | |
| Croatia | Clinical Hospital Dubrava | Zagreb | |
| Croatia | Clinicall Hospital "Merkur" | Zagreb | |
| 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 | |
| Estonia | North Estonian Regional Hospital | Tallin | |
| Estonia | Tartu University Hospital | Tartu | |
| Hong Kong | Queen Mary Hospital | Hong Kong | |
| Hong Kong | Tuen Mun Hospital | Hong Kong | |
| Israel | Soroka Medical Centre | Beer Sheva | |
| Israel | Rambam Medical Centre | Haifa | |
| Israel | Rabin Medical Centre | Petah-Tikva | |
| Israel | Kaplan Medical Centre | Rehovot | |
| Latvia | Riga Hematology Center | Riga | |
| Macedonia, The Former Yugoslav Republic of | Clinical Centre Skopje | Skopje | |
| Malaysia | Hospital Ampang | Ampang | |
| Malaysia | Hospital University Kebangsaan Malaysia | Kuala Lumpur | |
| Mexico | 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 | ISSSTEP Puebla | Puebla | |
| Peru | Hospital Carlso alberto seguin escobedo Arequipa | Arequipa | |
| Peru | Hospital Alberto Sabogal sooguren Callao | Callao | |
| Romania | Coltea Hospital | Bucharest | |
| Romania | Coltea Hospital | Bucharest | |
| Romania | University Emergency Center Bucharest | Bucharest | |
| Romania | Clinic Judatean de Urgenta Brasov | Targu Mures | |
| Romania | Emergency County Clinical Hospital | Targu Mures | |
| Russian Federation | Belgorod regional Clinical Hospital | Belgorod | |
| Russian Federation | Botkin City Clinical Hospital | Moscow | |
| Russian Federation | Moscow Regional Clinical Research Institute | Moscow | |
| Russian Federation | Novgorod Regional Clinical Hospital | Novgorod | |
| Russian Federation | Leningrad regional Cliniacal Hospital | St. Petersburg | |
| Russian Federation | SPB Pavlov State Medical University | St. Petersburg | |
| Russian Federation | Republican Clinic Oncology Dispensary | Ufa | |
| Serbia | Clinical centre of Serbia | Belgrade | |
| Serbia | Clinical Centre Nis | NIs | |
| Serbia | Clinical Centre Novi Sad | Novisad | |
| Serbia | Institute of Oncology Sremska Kamenica | Sremska Kamenica | |
| Slovakia | National Cancer Institut Bratislava | Bratislava | |
| Slovakia | OUSA Bratislava | Bratislava | |
| Slovakia | Východoslovenský onkolgický ústav | Kosice | |
| Slovakia | Martinská fakultná nemocnima | Martin | |
| Slovenia | Institut of Oncology Ljubljana | Ljubljana | |
| South Africa | Hopelands Cancer Centre | Pietremarizburg | |
| South Africa | Wilgers Oncology Centre | Pretoria | |
| Sweden | Falun Hospital | Falun | |
| Sweden | Sunderby Hospital | Lulea | |
| Sweden | Sundsvall Hospital | Sundsvall | |
| Sweden | Uddevalla Hospital | Uddevalla | |
| Taiwan | Kaohsiung Medical University Hospital | Kaohsiung | |
| Taiwan | Taichung Veterans General Hospital | Taipei | |
| Taiwan | Taipei Veterans General Hospital | Taipei | |
| Thailand | 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 | |
| Turkey | Ankara University, School of Medicine | Ankara | |
| Turkey | Osmangazi Univ. school of Medicine | Eskisehir | |
| Turkey | Gaziantep University School of Medicine | Gaziantep | |
| Turkey | Ericyes Univ. Med. School | Kayseri |
| Lead Sponsor | Collaborator |
|---|---|
| Arbeitsgemeinschaft medikamentoese Tumortherapie | Hoffmann-La Roche |
Australia, Austria, Bosnia and Herzegovina, Brazil, Bulgaria, China, Croatia, Czech Republic, Estonia, Hong Kong, Israel, Latvia, Macedonia, The Former Yugoslav Republic of, Malaysia, Mexico, Peru, Romania, Russian Federation, Serbia, Slovakia, Slovenia, South Africa, Sweden, Taiwan, Thailand, Turkey,
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. — View 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-NHL1 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | event free survival | 4 years | No | |
| Secondary | progression free survival, overall survival and safety | four years | Yes |
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