A Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation in Patients With Aggressive B-Cell Lymphoma: NHL-13
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Arbeitsgemeinschaft medikamentoese Tumortherapie.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborator:
Hoffmann-La Roche
Information provided by:
Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier:
NCT00400478
First received: November 16, 2006
Last updated: January 19, 2009
Last verified: January 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diffuse Large B-Cell Lymphoma (DLBCL) Follicular NHL Grade 3b |
Drug: Rituximab |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Further study details as provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:
Primary Outcome Measures:
- event free survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- progression free survival, overall survival and safety [ Time Frame: four years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 600 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
Treatment
|
Drug: Rituximab
Rituximab 375mg/m2 i every 8 weeks for two years (12 infusions)
|
|
No Intervention: B
Observation
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00400478
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Hide Study LocationsLocations
| Australia, Victoria | |
| Border Medical Oncology | |
| Wodonga, Victoria, Australia | |
| Australia | |
| Concord Repatriation General Hospital | |
| Concord, Australia | |
| Gosford Hospital | |
| Gosford, Australia | |
| Greenslopes Hospital | |
| Greenslopes, Australia | |
| Prince of Wales Hospital | |
| Sidney, Australia | |
| Austria | |
| Krankenhaus Oberpullendorf | |
| Oberpullendorf, Burgenland, Austria, A-7350 | |
| Krankenhaus Oberwart | |
| Oberwart, Burgenland, Austria, A-7400 | |
| A.ö. Krankenhaus der Landeshauptstadt St. Pölten | |
| St. Poelten, Niederoesterreich, Austria, A-3100 | |
| A.ö. Krankenhaus der Statutarstadt Wr. Neustadt | |
| Wr. Neustadt, Niederoesterreich, Austria, A-2770 | |
| Krankenhaus d. Barmherzigen Schwestern Linz | |
| Linz, Oberoesterreich, Austria, A-4010 | |
| Krankenhaus der Elisabethinen Linz | |
| Linz, Oberoesterreich, Austria, A-4010 | |
| KH Barmherzige Schwestern Ried | |
| Ried, Oberoesterreich, Austria, A-4910 | |
| Klinikum Kreuzschwestern Wels GmbH | |
| Wels, Oberösterreich, Austria, A-4600 | |
| A.ö. Landeskrankenhaus Steyr | |
| Steyr, Steiermark, Austria, A-4400 | |
| Bezirkskrankenhaus Kufstein | |
| Endach, Tirol, Austria, A-6330 | |
| A.oe.Bezirkskrankenhaus Hall | |
| Hall, Tirol, Austria, A-6060 | |
| Universitätsklinik Innsbruck/ Klinik für Innere Medizin | |
| Innsbruck, Tirol, Austria, A-6020 | |
| Landeskrankenhaus Feldkirch | |
| Feldkirch, Vorarlberg, Austria, A-6806 | |
| LKH Bregenz | |
| Bregenz, Austria, A-6900 | |
| KH Dornbirn | |
| Dornbirn, Austria, A-6850 | |
| A.ö. Landeskrankenhaus Fürstenfeld | |
| Fuerstenfeld, Austria, A-8280 | |
| Universitätsklinikum Graz | |
| Graz, Austria, A-8036 | |
| LKH Hohenems | |
| Hohenems, Austria, A-6845 | |
| Universitaetsklinik Innsbruck | |
| Innsbruck, Austria, A-6020 | |
| Landeskrankenhaus Klagenfurt | |
| Klagenfurt, Austria, A-9020 | |
| A.ö. Landeskrankenhaus Leoben | |
| Leoben, Austria, A-8700 | |
| Krankenhaus der Stadt Linz | |
| Linz, Austria, A-4020 | |
| LKH Weinviertel Mistelbach | |
| Mistelbach, Austria, A-2130 | |
| St. Johanns LK | |
| Salzburg, Austria, A-5020 | |
| Hanusch-Krankenhaus | |
| Vienna, Austria, A-1140 | |
| AKH Wien / Hämatologie u. Hämostaseologie | |
| Vienna, Austria, A-1090 | |
| Sozialmedizinisches Zentrum Ost - Donauspital | |
| Vienna, Austria, A-1220 | |
| Wilhelminenspital | |
| Vienna, Austria, A-1160 | |
| Krankenhaus der Stadt Wien Lainz | |
| Vienna, Austria, A-1130 | |
| Krankenhaus der Stadt Wien Rudolfsstiftung | |
| Vienna, Austria, A-1030 | |
| KH Barmherzige Brüder | |
| Vienna, Austria, A-1020 | |
| Kaiser-Franz-Josef-Spital | |
| Vienna, Austria, A-1100 | |
| LKH Villach | |
| Villach, Austria, A-9500 | |
| LKH Vöcklabruck | |
| Voecklabruck, Austria, A-4840 | |
| KH Waidhofen/Thaya | |
| Waidhofen, Austria, A-3830 | |
| BKH Zams | |
| Zams, Austria, A-6511 | |
| Bosnia and Herzegovina | |
| Clinical Centre University Sarajevo | |
| Sarajevo, Bosnia and Herzegovina, 71 000 | |
| University Center Tuzla | |
| Tuzla, Bosnia and Herzegovina, 75000 | |
| 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, Brazil | |
| Bulgaria | |
| UMHAT "St. George" Plodviv | |
| Plovdiv, Bulgaria | |
| Nat. Centre of Hematology and Transfusiology Sofia | |
| Sofia, Bulgaria | |
| MHAT "St. Marina" Varna | |
| Varna, Bulgaria | |
| 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, China | |
| Croatia | |
| Clinical Hopital Center Zagreb | |
| Zagreb, Croatia | |
| Clinicall Hospital "Merkur" | |
| Zagreb, Croatia | |
| Clinical Hospital Dubrava | |
| Zagreb, Croatia | |
| 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 | |
| University Hospital Motol | |
| Praha, Czech Republic | |
| Charles University Hospital | |
| Praha, Czech Republic | |
| RTO MN Usti n. Labem | |
| Usti nad Labem, Czech Republic | |
| Estonia | |
| North Estonian Regional Hospital | |
| Tallin, Estonia, 12915 | |
| Tartu University Hospital | |
| Tartu, Estonia, 15014 | |
| Hong Kong | |
| Queen Mary Hospital | |
| Hong Kong, Hong Kong | |
| Tuen Mun Hospital | |
| Hong Kong, Hong Kong | |
| Israel | |
| Soroka Medical Centre | |
| Beer Sheva, Israel | |
| Rambam Medical Centre | |
| Haifa, Israel | |
| Rabin Medical Centre | |
| Petah-Tikva, Israel | |
| Kaplan Medical Centre | |
| Rehovot, Israel | |
| Latvia | |
| Riga Hematology Center | |
| Riga, Latvia | |
| Macedonia, The Former Yugoslav Republic of | |
| Clinical Centre Skopje | |
| Skopje, Macedonia, The Former Yugoslav Republic of | |
| Malaysia | |
| Hospital Ampang | |
| Ampang, Malaysia | |
| Hospital University Kebangsaan Malaysia | |
| Kuala Lumpur, Malaysia | |
| Mexico | |
| ISSSTE Hospital Regional de Leon | |
| Leon, Mexico | |
| Instituto National de Cancerologia | |
| Mexico City, Mexico | |
| Hospital General de Mexico | |
| Mexico City, Mexico | |
| Hospital Espanol de Mexico | |
| Mexico City, Mexico | |
| Hospital Regional Monterrey, ISSTE | |
| Monterrey, Mexico | |
| ISSSTEP Puebla | |
| Puebla, Mexico | |
| Peru | |
| Hospital Carlso alberto seguin escobedo Arequipa | |
| Arequipa, Peru | |
| Hospital Alberto Sabogal sooguren Callao | |
| Callao, Peru | |
| Romania | |
| Coltea Hospital | |
| Bucharest, Romania, 22328 | |
| Coltea Hospital | |
| Bucharest, Romania | |
| University Emergency Center Bucharest | |
| Bucharest, Romania | |
| Clinic Judatean de Urgenta Brasov | |
| Targu Mures, Romania | |
| Emergency County Clinical Hospital | |
| Targu Mures, Romania | |
| Russian Federation | |
| Belgorod regional Clinical Hospital | |
| Belgorod, Russian Federation, 308007 | |
| Moscow Regional Clinical Research Institute | |
| Moscow, Russian Federation, 115478 | |
| Botkin City Clinical Hospital | |
| Moscow, Russian Federation, 125101 | |
| Novgorod Regional Clinical Hospital | |
| Novgorod, Russian Federation, 603126 | |
| SPB Pavlov State Medical University | |
| St. Petersburg, Russian Federation, 197089 | |
| Leningrad regional Cliniacal Hospital | |
| St. Petersburg, Russian Federation, 194291 | |
| Republican Clinic Oncology Dispensary | |
| Ufa, Russian Federation, 450054 | |
| Serbia | |
| Clinical centre of Serbia | |
| Belgrade, Serbia, 11000 | |
| Clinical Centre Nis | |
| NIs, Serbia, 18000 | |
| Clinical Centre Novi Sad | |
| Novisad, Serbia, 11000 | |
| Institute of Oncology Sremska Kamenica | |
| Sremska Kamenica, Serbia, 21204 | |
| Slovakia | |
| National Cancer Institut Bratislava | |
| Bratislava, Slovakia | |
| OUSA Bratislava | |
| Bratislava, Slovakia | |
| Východoslovenský onkolgický ústav | |
| Kosice, Slovakia | |
| Martinská fakultná nemocnima | |
| Martin, Slovakia | |
| Slovenia | |
| Institut of Oncology Ljubljana | |
| Ljubljana, Slovenia, 1100 | |
| South Africa | |
| Hopelands Cancer Centre | |
| Pietremarizburg, South Africa | |
| Wilgers Oncology Centre | |
| Pretoria, South Africa | |
| Sweden | |
| Falun Hospital | |
| Falun, Sweden, 79182 | |
| Sunderby Hospital | |
| Lulea, Sweden, 97180 | |
| Sundsvall Hospital | |
| Sundsvall, Sweden, 85186 | |
| Uddevalla Hospital | |
| Uddevalla, Sweden, 45180 | |
| Taiwan | |
| Kaohsiung Medical University Hospital | |
| Kaohsiung, Taiwan, 807 | |
| Taichung Veterans General Hospital | |
| Taipei, Taiwan | |
| Taipei Veterans General Hospital | |
| Taipei, Taiwan, 112 | |
| Thailand | |
| King Chulalongkorn Memorial Hospital | |
| Bangkok, Thailand | |
| Siriray Hospital | |
| Bangkok, Thailand | |
| Ramathibodi Hospital | |
| Bangkok, Thailand | |
| Phramongkutklao College of Medicine | |
| Bangkok, Thailand | |
| Chiang Mai University | |
| Chiang Mai, Thailand | |
| Srinagarind Hospital | |
| Khon kaen, Thailand | |
| Songklanagrarind Hospital | |
| Songkla, Thailand | |
| Turkey | |
| Ankara University, School of Medicine | |
| Ankara, Turkey, 06620 | |
| Osmangazi Univ. school of Medicine | |
| Eskisehir, Turkey, 26480 | |
| Gaziantep University School of Medicine | |
| Gaziantep, Turkey, 27310 | |
| Ericyes Univ. Med. School | |
| Kayseri, Turkey, 38039 | |
Sponsors and Collaborators
Arbeitsgemeinschaft medikamentoese Tumortherapie
Hoffmann-La Roche
Investigators
| Principal Investigator: | Ulrich Jaeger, Prof. Dr. | Medical University of Vienna |
More Information
No publications provided
| Responsible Party: | Prof. Ulrich Jäger, AGMT |
| ClinicalTrials.gov Identifier: | NCT00400478 History of Changes |
| Other Study ID Numbers: | NHL-13 (ML18223) |
| Study First Received: | November 16, 2006 |
| Last Updated: | January 19, 2009 |
| Health Authority: | Austria: Ethikkommission |
Keywords provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:
|
DLBCL NHL 13 Rituximab maintenance |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Lymphoma, Non-Hodgkin Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 22, 2013