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| ID | Type | Description | Link |
|---|---|---|---|
| 304820 | |||
| NHL FIT |
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The aim of the study is to test [90]Y-ibritumomab tiuxetan, a radioactive antibody, in patients with stage III or IV follicular lymphoma whose disease is in partial or complete remission after first line chemotherapy. The radioactive antibody will be compared with no further treatment to see which is better in the long term after standard lymphoma treatment.
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zevalin ([90]Y-ibritumomab tiuxetan, BAY86-5128) | Biological | treatment with 90 Yttrium-labeled anti CD 20 antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | End of study |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical and molecular response rates | End of study | |
| Overall survival | End of study | |
| Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antwerp | 2020 | Belgium | ||||
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| no treatment | Other | no treatment |
|
| End of study |
| Adverse events / Toxicity Grading | Continous |
| Clinical laboratory results | 3 monthly |
| Vital signs / physical examination | 3 monthly |
| ECG | End of study |
| Co-medication | Continous |
| Bruges |
| 8000 |
| Belgium |
| Brussels | 1000 | Belgium |
| Ghent | 9000 | Belgium |
| Leuven | 3000 | Belgium |
| Yvoir | 5530 | Belgium |
| Edmonton | Alberta | T6G 1Z2 | Canada |
| Vancouver | British Columbia | V5Z 4E6 | Canada |
| Hamilton | Ontario | L8V 5C2 | Canada |
| Ottawa | Ontario | K1H 8L6 | Canada |
| Toronto | Ontario | M4N 3M5 | Canada |
| Toronto | Ontario | M5G 2M9 | Canada |
| Montreal | Quebec | H1T 2M4 | Canada |
| Montreal | Quebec | H3A 1A1 | Canada |
| Aarhus | DK-8000 | Denmark |
| Copenhagen | 2100 | Denmark |
| Rennes | Brittany Region | 35038 | France |
| Angers | 49033 | France |
| Besançon | 25030 | France |
| Bordeaux | 33076 | France |
| Créteil | 94010 | France |
| Grenoble | 38043 | France |
| Le Mans | 72000 | France |
| Lille | 59037 | France |
| Lyon | 69003 | France |
| Paris | 75743 | France |
| Pierre-Bénite | 69495 | France |
| Rouen | 76038 | France |
| Strasbourg | 67098 | France |
| Tours | 37000 | France |
| Tübingen | Baden-Wurttemberg | 72076 | Germany |
| Augsburg | Bavaria | 86156 | Germany |
| München | Bavaria | 81675 | Germany |
| Göttingen | Lower Saxony | 37099 | Germany |
| Münster | Nordrhein-Westfalen / 298 | 48129 | Germany |
| Hamm | Nordrhein-Westfalen / 358 | 59071 | Germany |
| Cologne | North Rhine-Westphalia | 50924 | Germany |
| Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
| Dresden | Saxony | 01309 | Germany |
| Hamburg | 20099 | Germany |
| Bologna | BO | 40138 | Italy |
| San Giovanni Rotondo | Foggia | 71013 | Italy |
| Milan | MI | 20122 | Italy |
| Milan | MI | 20132 | Italy |
| Rozzano | MI | 20089 | Italy |
| Pisa | PI | 56126 | Italy |
| Roma | Roma | 00144 | Italy |
| Torino | TO | 10126 | Italy |
| Milan | 20141 | Italy |
| Naples | 80131 | Italy |
| Palermo | 90146 | Italy |
| Amersfoort | 3800 BM | Netherlands |
| Amsterdam | 1081 HV | Netherlands |
| Amsterdam | Netherlands |
| Eindhoven | 5623 EJ | Netherlands |
| Enschede | 7511 JX | Netherlands |
| Groningen | 9713 GZ | Netherlands |
| Leiden | 2333 ZA | Netherlands |
| Maastricht | 6229 HX | Netherlands |
| Nijmegen | 6500 HB | Netherlands |
| Rotterdam | 3015 GD | Netherlands |
| The Hague | 2545 CH | Netherlands |
| Utrecht | 3584 CX | Netherlands |
| Zwolle | 8025 AB | Netherlands |
| Oslo | 0310 | Norway |
| Tromsø | N-9038 | Norway |
| Coimbra | 3000-076 | Portugal |
| Lisbon | 1070-213 | Portugal |
| Lisbon | 1649-035 | Portugal |
| Porto | 4200-072 | Portugal |
| L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Barcelona | 08025 | Spain |
| Barcelona | 08036 | Spain |
| Madrid | 28007 | Spain |
| Madrid | 28040 | Spain |
| Málaga | 29010 | Spain |
| Salamanca | 37007 | Spain |
| Valencia | 46010 | Spain |
| Gothenburg | 41685 | Sweden |
| Umeå | 901 85 | Sweden |
| Uppsala | S-751 85 | Sweden |
| Zurich | Bern / 633 | 8091 | Switzerland |
| Sankt Gallen | Saint Gallen / 633 | 9007 | Switzerland |
| Aarau | 5000 | Switzerland |
| Bellinzona | 6500 | Switzerland |
| Bern | 3010 | Switzerland |
| Geneva | 1211 | Switzerland |
| Lausanne | 1011 | Switzerland |
| Glasgow | G11 6NT | United Kingdom |
| London | EC1A 7BE | United Kingdom |
| London | NW3 2PF | United Kingdom |
| Manchester | M20 4BX | United Kingdom |
| Newcastle upon Tyne | NE1 4LP | United Kingdom |
| Plymouth | PL6 8DH | United Kingdom |
| Surrey | SM2 5PT | United Kingdom |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| 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 |
|---|---|
| C422802 | ibritumomab tiuxetan |
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