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| Sponsor: | Hoffmann-La Roche |
|---|---|
| Information provided by: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00430352 |
Purpose
This single arm study will evaluate the safety and efficacy of MabThera maintenance therapy following a MabThera-containing induction regimen in first line or relapsed patients with follicular non-Hodgkin's lymphoma. All patients will receive MabThera 375mg/m2 body surface area, as an intravenous infusion, every 8 weeks. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Hodgkin's Lymphoma |
Drug: rituximab [MabThera/Rituxan] |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Study to Evaluate the Safety of MabThera (Rituximab) Maintenance Therapy in Patients With Follicular Non-Hodgkin's Lymphoma Who Have Responded to Induction Therapy. |
| Estimated Enrollment: | 500 |
| Study Start Date: | September 2006 |
| Estimated Study Completion Date: | March 2011 |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: rituximab [MabThera/Rituxan]
375mg/m2 iv every 8 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| Albania | |
| Tirana, Albania | |
| Argentina | |
| Córdoba, Argentina, 5016 | |
| Buenos Aires, Argentina, C1114AAN | |
| La Plata, Argentina, B1904CFS | |
| Buenos Aires, Argentina, 1425 | |
| Buenos Aires, Argentina, C1437JCP | |
| Córdoba, Argentina, 5000 | |
| Corrientes, Argentina, 3400 | |
| Bahia Blanca, Argentina, 8001 | |
| Australia | |
| Wollongong, Australia, 2500 | |
| Liverpool, Australia, 1871 | |
| Brisbane, Australia, 4006 | |
| Perth, Australia, 6000 | |
| South Brisbane, Australia, 4101 | |
| Bosnia and Herzegovina | |
| Sarajevo, Bosnia and Herzegovina, 71000 | |
| Banja Luka, Bosnia and Herzegovina, 88000 | |
| Mostar, Bosnia and Herzegovina, 88000 | |
| Kasindo, Bosnia and Herzegovina, 71123 | |
| Brazil | |
| Porto Alegre, Brazil, 90610-000 | |
| Salvador, Brazil, 40170-070 | |
| Sao Paulo, Brazil, 01509-900 | |
| Sao Paulo, Brazil, 05403 | |
| Rio de Janeiro, Brazil, 22640-000 | |
| Porto Alegre, Brazil, 90035-003 | |
| Porto Alegre, Brazil, 90035-001 | |
| Belo Horizonte, Brazil, 30140-083 | |
| Florianopolis, Brazil, 88020-200 | |
| Salvador, Brazil, 40110-150 | |
| Campinas, Brazil, 13083-878 | |
| Piracicaba, Brazil, 13419-155 | |
| Sao Paulo, Brazil, 04039-901 | |
| Bulgaria | |
| Sofia, Bulgaria, 1431 | |
| Varna, Bulgaria, 9002 | |
| Sofia, Bulgaria, 1757 | |
| Plovdiv, Bulgaria, 4000 | |
| Pleven, Bulgaria, 5800 | |
| Colombia | |
| Bucaramanga, Colombia | |
| Medellin, Colombia | |
| Croatia | |
| Zagreb, Croatia, 10000 | |
| Split, Croatia, 21000 | |
| Ecuador | |
| Quito, Ecuador, 2569 | |
| Cuenca, Ecuador | |
| Egypt | |
| Cairo, Egypt, 11737 | |
| Finland | |
| Kuopio, Finland, 70211 | |
| Pori, Finland, 28500 | |
| Haemeenlinna, Finland, 13530 | |
| Kotka, Finland, 48210 | |
| Lahti, Finland, 15850 | |
| Germany | |
| Bad Soden, Germany, 65812 | |
| Berlin, Germany, 10709 | |
| Erlangen, Germany, 91052 | |
| Freiburg, Germany, 79117 | |
| Gütersloh, Germany, 33332 | |
| Hamburg, Germany, 20095 | |
| Hamburg, Germany, 22457 | |
| Heidelberg, Germany, 69120 | |
| Braunschweig, Germany, 38100 | |
| Jena, Germany, 07743 | |
| Minden, Germany, 32427 | |
| München, Germany, 80335 | |
| Mutlangen, Germany, 73557 | |
| Oldenburg, Germany, 26121 | |
| Schwäbisch-hall, Germany, 74523 | |
| Stuttgart, Germany, 70176 | |
| Würselen, Germany, 52146 | |
| Troisdorf, Germany, 53840 | |
| Heidelberg, Germany, 69115 | |
| Duisburg, Germany, 47051 | |
| Bonn, Germany, 53127 | |
| Düsseldorf, Germany, 40211 | |
| Lüdenscheid, Germany, 58515 | |
| Mülheim, Germany, 45468 | |
| Recklinghausen, Germany, 45657 | |
| Berlin, Germany, 10117 | |
| Nordhorn, Germany, 48527 | |
| Greece | |
| Athens, Greece, 11524 | |
| Thessaloniki, Greece, 54007 | |
| Athens, Greece, 12462 | |
| Israel | |
| Jerusalem, Israel, 91120 | |
| Ramat Gan, Israel, 52662 | |
| Tel Aviv, Israel, 64239 | |
| Haifa, Israel, 31096 | |
| Holon, Israel, 58251 | |
| Italy | |
| Bologna, Italy, 40138 | |
| Modena, Italy, 41100 | |
| Firenze, Italy, 50135 | |
| Milano, Italy, 20133 | |
| Catania, Italy, 95124 | |
| Cagliari, Italy, 09121 | |
| Napoli, Italy, 80131 | |
| Pescara, Italy, 65100 | |
| Cuneo, Italy, 12100 | |
| Siena, Italy, 53100 | |
| Pavia, Italy, 27100 | |
| Roma, Italy, 00168 | |
| Bari, Italy, 70124 | |
| Roma, Italy, 00161 | |
| Perugia, Italy, 06100 | |
| Palermo, Italy, 90146 | |
| Catanzaro, Italy, 88100 | |
| Milano, Italy, 20162 | |
| Candiolo, Italy, 10060 | |
| Vicenza, Italy, 36100 | |
| Brescia, Italy, 25123 | |
| Torino, Italy, 10126 | |
| Pesaro, Italy, 61100 | |
| Milano, Italy, 20132 | |
| Ferrara, Italy, 44100 | |
| Novara, Italy, 28100 | |
| Napoli, Italy, 80100 | |
| Torrette Di Ancona, Italy, 60020 | |
| Pisa, Italy, 56100 | |
| Padova, Italy, 35128 | |
| Tricase - Le, Italy, 73039 | |
| Aviano, Italy, 33081 | |
| Roma, Italy, 00144 | |
| Roma, Italy, 00133 | |
| Genova, Italy, 16132 | |
| Lecce, Italy, 73100 | |
| Monza, Italy, 20052 | |
| Mexico | |
| Chihuahua, Mexico, 31100 | |
| Mexico City, Mexico, 02720 | |
| Mexico City, Mexico, 11520 | |
| Chihuahua, Mexico, 31238 | |
| Obregon, Mexico, 85000 | |
| Monterrey, Mexico, 64380 | |
| Puebla, Mexico, 72530 | |
| Romania | |
| Bucharest, Romania, 030 171 | |
| Bucharest, Romania, 022 328 | |
| Targu-mures, Romania, 540136 | |
| Cluj-napoca, Romania, 400015 | |
| Iasi, Romania, 5000 | |
| Brasov, Romania, 500326 | |
| Russian Federation | |
| Moscow, Russian Federation, 115478 | |
| Moscow, Russian Federation, 125101 | |
| Moscow, Russian Federation, 129110 | |
| St Petersburg, Russian Federation, 191024 | |
| St Petersburg, Russian Federation, 197089 | |
| St Petersburg, Russian Federation, ND | |
| Belgorod, Russian Federation, ND | |
| Nizhny Novgorod, Russian Federation, 603126 | |
| Volgograd, Russian Federation, 400138 | |
| Stavropol, Russian Federation, ND | |
| Rostov-na-donu, Russian Federation, 344022 | |
| Yaroslavl, Russian Federation, 150062 | |
| Ufa, Russian Federation, 450054 | |
| Ulyanovsk, Russian Federation, ND | |
| Kazan, Russian Federation, 420029 | |
| Novosibirsk, Russian Federation, 630051 | |
| Slovakia | |
| Bratislava, Slovakia, 833 10 | |
| Kosice, Slovakia, 040 66 | |
| Martin, Slovakia, 036 59 | |
| Banska Bystrica, Slovakia, 975 17 | |
| Slovenia | |
| Ljubljana, Slovenia, 1000 | |
| Spain | |
| Castellon, Spain, 12004 | |
| Jaen, Spain, 23007 | |
| Malaga, Spain, 29600 | |
| Sevilla, Spain, 41009 | |
| Valencia, Spain, 46010 | |
| El Palmar Murcia, Spain, 30120 | |
| Ciudad Real, Spain, 13005 | |
| Burgos, Spain, 09005 | |
| Leon, Spain, 24411 | |
| Sweden | |
| Lulea, Sweden, 97180 | |
| Malmo, Sweden, 205 02 | |
| Uddevalla, Sweden, 45180 | |
| Sundsvall, Sweden, 85186 | |
| Halmstad, Sweden, 30185 | |
| Uppsala, Sweden, 75185 | |
| Switzerland | |
| Cham, Switzerland, 6330 | |
| Chur, Switzerland, 7000 | |
| Locarno, Switzerland, 6601 | |
| Zürich, Switzerland, 8091 | |
| Turkey | |
| Ankara, Turkey, 06100 | |
| Ankara, Turkey, 06100 | |
| Ankara, Turkey, 06500 | |
| Izmir, Turkey, 35100 | |
| Istanbul, Turkey, 34390 | |
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
| Responsible Party: | Hoffmann-La Roche ( Disclosures Group ) |
| Study ID Numbers: | MO19872 |
| Study First Received: | January 31, 2007 |
| Last Updated: | November 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00430352 History of Changes |
| Health Authority: | Italy: Ministry of Health |
|
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Immunologic Factors Antineoplastic Agents Rituximab Physiological Effects of Drugs Lymphoma, Follicular |
Pharmacologic Actions Lymphatic Diseases Neoplasms Therapeutic Uses Antirheumatic Agents Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |
