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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

Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT00185393
Collaborator
(none)
414
Enrollment
95
Locations
2
Arms
66
Duration (Months)
4.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Zevalin ([90]Y-ibritumomab tiuxetan, BAY86-5128)
  • Other: no treatment
 Phase 3

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
414 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Subsequent Treatment With [90]Y-Ibritumomab Tiuxetan Versus no Further Treatment in Patients With Stage III or IV Follicular Non-Hodgkin's Lymphoma Having Achieved Partial or Complete Remission After First Line Chemotherapy. A Prospective, Multicenter, Randomized Phase III Clinical Trial
Study Start Date :
Aug 1, 2001
Actual Study Completion Date :
Feb 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1

Biological: Zevalin ([90]Y-ibritumomab tiuxetan, BAY86-5128)
treatment with 90 Yttrium-labeled anti CD 20 antibody
Other: Arm 2

Other: no treatment
no treatment

Outcome Measures

Primary Outcome Measures

  1. Progression free survival [End of study]

Secondary Outcome Measures

  1. Clinical and molecular response rates [End of study]

  2. Overall survival [End of study]

  3. Quality of Life [End of study]

  4. Adverse events / Toxicity Grading [Continous]

  5. Clinical laboratory results [3 monthly]

  6. Vital signs / physical examination [3 monthly]

  7. ECG [End of study]

  8. Co-medication [Continous]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Antwerpen Belgium 2020
2 Brugge Belgium 8000
3 Bruxelles Belgium 1000
4 Gent Belgium 9000
5 Leuven Belgium 3000
6 Yvoir Belgium 5530
7 Edmonton Alberta Canada T6G 1Z2
8 Vancouver British Columbia Canada V5Z 4E6
9 Hamilton Ontario Canada L8V 5C2
10 Ottawa Ontario Canada K1H 8L6
11 Toronto Ontario Canada M4N 3M5
12 Toronto Ontario Canada M5G 2M9
13 Montreal Quebec Canada H1T 2M4
14 Montreal Quebec Canada H3A 1A1
15 Aarhus Denmark DK-8000
16 Copenhagen Denmark 2100
17 Rennes Bretagne France 35038
18 Angers Cedex 1 France 49033
19 Besancon France 25030
20 Bordeaux France 33076
21 Creteil France 94010
22 Grenoble Cedex 9 France 38043
23 Le Mans France 72000
24 Lille France 59037
25 Lyon France 69003
26 Paris Cedex 15 France 75743
27 Pierre Benite France 69495
28 Rouen France 76038
29 Strasbourg France 67098
30 Tours France 37000
31 Tübingen Baden-Wuerttemberg Germany 72076
32 Augsburg Bayern Germany 86156
33 München Bayern Germany 81675
34 Göttingen Niedersachsen Germany 37099
35 Münster Nordrhein-Westfalen / 298 Germany 48129
36 Hamm Nordrhein-Westfalen / 358 Germany 59071
37 Düsseldorf Nordrhein-Westfalen Germany 40225
38 Köln Nordrhein-Westfalen Germany 50924
39 Dresden Sachsen Germany 01309
40 Hamburg Germany 20099
41 Bologna BO Italy 40138
42 San Giovanni Rotondo Foggia Italy 71013
43 Milano MI Italy 20122
44 Milano MI Italy 20132
45 Rozzano MI Italy 20089
46 Pisa PI Italy 56126
47 Torino TO Italy 10126
48 Milano Italy 20141
49 Napoli Italy 80131
50 Palermo Italy 90146
51 Roma Italy 00144
52 Amersfoort Netherlands 3800 BM
53 Amsterdam Netherlands 1081 HV
54 Amsterdam Netherlands
55 Den Haag Netherlands 2545 CH
56 Eindhoven Netherlands 5623 EJ
57 Enschede Netherlands 7511 JX
58 Groningen Netherlands 9713 GZ
59 Leiden Netherlands 2333 ZA
60 Maastricht Netherlands 6229 HX
61 Nijmegen Netherlands 6500 HB
62 Rotterdam Netherlands 3015 GD
63 Utrecht Netherlands 3584 CX
64 Zwolle Netherlands 8025 AB
65 Oslo Norway 0310
66 Tromso Norway N-9038
67 Coimbra Portugal 3000-076
68 Lisboa Portugal 1070-213
69 Lisboa Portugal 1649-035
70 Porto Portugal 4200-072
71 Hospitalet de Llobregat Barcelona Spain 08907
72 Barcelona Spain 08025
73 Barcelona Spain 08036
74 Madrid Spain 28007
75 Madrid Spain 28040
76 Malaga Spain 29010
77 Salamanca Spain 37007
78 Valencia Spain 46010
79 Göteborg Sweden 41685
80 Umeå Sweden 901 85
81 Uppsala Sweden S-751 85
82 Zürich Bern / 633 Switzerland 8091
83 St. Gallen St. Gallen / 633 Switzerland 9007
84 Aarau Switzerland 5000
85 Bellinzona Switzerland 6500
86 Bern Switzerland 3010
87 Geneva Switzerland 1211
88 Lausanne Switzerland 1011
89 Glasgow United Kingdom G11 6NT
90 London United Kingdom EC1A 7BE
91 London United Kingdom NW3 2PF
92 Manchester United Kingdom M20 4BX
93 Newcastle-Upon-Tyne United Kingdom NE1 4LP
94 Plymouth United Kingdom PL6 8DH
95 Surrey United Kingdom SM2 5PT

Sponsors and Collaborators

  • Bayer

Investigators

  • Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00185393
Other Study ID Numbers:
  • 90966
  • 304820
  • NHL FIT
First Posted:
Sep 16, 2005
Last Update Posted:
Dec 1, 2008
Last Verified:
Nov 1, 2008
Keywords provided by , ,
Follicular Non Hodgkin lymphoma
Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Follicular

Study Results

No Results Posted as of Dec 1, 2008