Treatment With [90]Y-Ibritumomab Tiuxetan Versus no Treatment in Patients With Follicular Non Hodgkin Lymphoma (Stage III or IV) Having Achieved a Partial or Complete Remission After First Line Chemotherapy

NCT00185393 | Completed Phase 3

• 3 other identifiers: 90966304820NHL FIT
• Study Type: interventional
• Target: 414
• Locations: 13 countries
• Sites: 95

Brief Summary

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.

Conditions

Lymphoma, Non-Hodgkin

Keywords

Follicular Non Hodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  End of study

Secondary Outcomes (8)

• Clinical and molecular response rates

  End of study

• Overall survival

  End of study

• Quality of Life

  End of study

• Adverse events / Toxicity Grading

  Continous

• Clinical laboratory results

  3 monthly

Study Arms (2)

Arm 1

EXPERIMENTAL

Biological: Zevalin ([90]Y-ibritumomab tiuxetan, BAY86-5128)

Arm 2

OTHER

Other: no treatment

Interventions

Zevalin ([90]Y-ibritumomab tiuxetan, BAY86-5128) BIOLOGICAL

treatment with 90 Yttrium-labeled anti CD 20 antibody

Arm 1

no treatment OTHER

no treatment

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non Hodgkin Lymphoma stage III or IV at timepoint of diagnosis
• Patients who have achieved a remission after first line chemotherapy
• No less than 6 weeks and no more than 12 weeks since last dose of chemotherapy
• older than 18 years
• written informed consent

You may not qualify if:

• Any other anticancer treatment for NHL except the preceding first line chemotherapy
• Prior radiation therapy
• Patients who have not recovered from the toxic effects of the first line chemotherapy
• Any other cancer or history of cancer less than 10 years ago
• Patients with known HIV positivity
• patients with pleural effusion or ascites
• female patients who are pregnant or breast feeding (women of childbearing potential must have a negative serum pregnancy test at study entry)
• Adults not employing an effective method of birth control during study treatment and 12 months thereafter
• Patients unable or unwilling to comply with protocol

Sponsors & Collaborators

• Bayer: lead

Study Sites (95)

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Antwerp, 2020, Belgium

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Bruges, 8000, Belgium

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Brussels, 1000, Belgium

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Ghent, 9000, Belgium

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Leuven, 3000, Belgium

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Yvoir, 5530, Belgium

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Edmonton, Alberta, T6G 1Z2, Canada

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Vancouver, British Columbia, V5Z 4E6, Canada

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Hamilton, Ontario, L8V 5C2, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Toronto, Ontario, M5G 2M9, Canada

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Montreal, Quebec, H1T 2M4, Canada

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Montreal, Quebec, H3A 1A1, Canada

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Aarhus, DK-8000, Denmark

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Copenhagen, 2100, Denmark

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Rennes, Brittany Region, 35038, France

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Angers, 49033, France

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Besançon, 25030, France

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Bordeaux, 33076, France

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Créteil, 94010, France

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Grenoble, 38043, France

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Le Mans, 72000, France

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Lille, 59037, France

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Lyon, 69003, France

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Paris, 75743, France

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Pierre-Bénite, 69495, France

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Rouen, 76038, France

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Strasbourg, 67098, France

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Tours, 37000, France

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Tübingen, Baden-Wurttemberg, 72076, Germany

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Augsburg, Bavaria, 86156, Germany

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München, Bavaria, 81675, Germany

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Göttingen, Lower Saxony, 37099, Germany

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Münster, Nordrhein-Westfalen / 298, 48129, Germany

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Hamm, Nordrhein-Westfalen / 358, 59071, Germany

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Cologne, North Rhine-Westphalia, 50924, Germany

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Düsseldorf, North Rhine-Westphalia, 40225, Germany

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Dresden, Saxony, 01309, Germany

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Hamburg, 20099, Germany

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Bologna, BO, 40138, Italy

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San Giovanni Rotondo, Foggia, 71013, Italy

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Milan, MI, 20122, Italy

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Milan, MI, 20132, Italy

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Rozzano, MI, 20089, Italy

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Pisa, PI, 56126, Italy

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Roma, Roma, 00144, Italy

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Torino, TO, 10126, Italy

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Milan, 20141, Italy

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Napoli, 80131, Italy

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Palermo, 90146, Italy

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Amersfoort, 3800 BM, Netherlands

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Amsterdam, 1081 HV, Netherlands

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Amsterdam, Netherlands

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Eindhoven, 5623 EJ, Netherlands

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Enschede, 7511 JX, Netherlands

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Groningen, 9713 GZ, Netherlands

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Leiden, 2333 ZA, Netherlands

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Maastricht, 6229 HX, Netherlands

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Nijmegen, 6500 HB, Netherlands

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Rotterdam, 3015 GD, Netherlands

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The Hague, 2545 CH, Netherlands

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Utrecht, 3584 CX, Netherlands

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Zwolle, 8025 AB, Netherlands

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Oslo, 0310, Norway

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Tromsø, N-9038, Norway

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Coimbra, 3000-076, Portugal

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Lisbon, 1070-213, Portugal

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Lisbon, 1649-035, Portugal

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Porto, 4200-072, Portugal

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L'Hospitalet de Llobregat, Barcelona, 08907, Spain

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Barcelona, 08025, Spain

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Barcelona, 08036, Spain

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Madrid, 28007, Spain

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Madrid, 28040, Spain

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Málaga, 29010, Spain

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Salamanca, 37007, Spain

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Valencia, 46010, Spain

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Gothenburg, 41685, Sweden

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Umeå, 901 85, Sweden

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Uppsala, S-751 85, Sweden

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Zurich, Bern / 633, 8091, Switzerland

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Sankt Gallen, Saint Gallen / 633, 9007, Switzerland

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Aarau, 5000, Switzerland

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Bellinzona, 6500, Switzerland

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Bern, 3010, Switzerland

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Geneva, 1211, Switzerland

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Lausanne, 1011, Switzerland

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Glasgow, G11 6NT, United Kingdom

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London, EC1A 7BE, United Kingdom

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London, NW3 2PF, United Kingdom

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Manchester, M20 4BX, United Kingdom

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Newcastle upon Tyne, NE1 4LP, United Kingdom

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Plymouth, PL6 8DH, United Kingdom

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Surrey, SM2 5PT, United Kingdom

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MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, Follicular

Interventions

ibritumomab tiuxetan

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: August 1, 2001
• Study Completion: February 1, 2007
• Last Updated: December 1, 2008

Record last verified: 2008-11

Locations

CA (8); CH (7); ES (8); GB (7); PT (4); NL (13); DK (2); SE (3); NO (2); IT (11); BE (6); FR (14); DE (10)