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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

Primary Purpose

Lymphoma, Non-Hodgkin

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Zevalin ([90]Y-ibritumomab tiuxetan, BAY86-5128)
no treatment
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring Follicular Non Hodgkin lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

Progression free survival

Secondary Outcome Measures

Clinical and molecular response rates
Overall survival
Quality of Life
Adverse events / Toxicity Grading
Clinical laboratory results
Vital signs / physical examination
ECG
Co-medication

Full Information

First Posted
September 12, 2005
Last Updated
November 26, 2008
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00185393
Brief Title
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
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 Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin
Keywords
Follicular Non Hodgkin lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
414 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
Zevalin ([90]Y-ibritumomab tiuxetan, BAY86-5128)
Intervention Description
treatment with 90 Yttrium-labeled anti CD 20 antibody
Intervention Type
Other
Intervention Name(s)
no treatment
Intervention Description
no treatment
Primary Outcome Measure Information:
Title
Progression free survival
Time Frame
End of study
Secondary Outcome Measure Information:
Title
Clinical and molecular response rates
Time Frame
End of study
Title
Overall survival
Time Frame
End of study
Title
Quality of Life
Time Frame
End of study
Title
Adverse events / Toxicity Grading
Time Frame
Continous
Title
Clinical laboratory results
Time Frame
3 monthly
Title
Vital signs / physical examination
Time Frame
3 monthly
Title
ECG
Time Frame
End of study
Title
Co-medication
Time Frame
Continous

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
City
Gent
ZIP/Postal Code
9000
Country
Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
City
Aarhus
ZIP/Postal Code
DK-8000
Country
Denmark
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
City
Rennes
State/Province
Bretagne
ZIP/Postal Code
35038
Country
France
City
Angers Cedex 1
ZIP/Postal Code
49033
Country
France
City
Besancon
ZIP/Postal Code
25030
Country
France
City
Bordeaux
ZIP/Postal Code
33076
Country
France
City
Creteil
ZIP/Postal Code
94010
Country
France
City
Grenoble Cedex 9
ZIP/Postal Code
38043
Country
France
City
Le Mans
ZIP/Postal Code
72000
Country
France
City
Lille
ZIP/Postal Code
59037
Country
France
City
Lyon
ZIP/Postal Code
69003
Country
France
City
Paris Cedex 15
ZIP/Postal Code
75743
Country
France
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
City
Rouen
ZIP/Postal Code
76038
Country
France
City
Strasbourg
ZIP/Postal Code
67098
Country
France
City
Tours
ZIP/Postal Code
37000
Country
France
City
Tübingen
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
72076
Country
Germany
City
Augsburg
State/Province
Bayern
ZIP/Postal Code
86156
Country
Germany
City
München
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
City
Göttingen
State/Province
Niedersachsen
ZIP/Postal Code
37099
Country
Germany
City
Münster
State/Province
Nordrhein-Westfalen / 298
ZIP/Postal Code
48129
Country
Germany
City
Hamm
State/Province
Nordrhein-Westfalen / 358
ZIP/Postal Code
59071
Country
Germany
City
Düsseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40225
Country
Germany
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50924
Country
Germany
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01309
Country
Germany
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
City
San Giovanni Rotondo
State/Province
Foggia
ZIP/Postal Code
71013
Country
Italy
City
Milano
State/Province
MI
ZIP/Postal Code
20122
Country
Italy
City
Milano
State/Province
MI
ZIP/Postal Code
20132
Country
Italy
City
Rozzano
State/Province
MI
ZIP/Postal Code
20089
Country
Italy
City
Pisa
State/Province
PI
ZIP/Postal Code
56126
Country
Italy
City
Torino
State/Province
TO
ZIP/Postal Code
10126
Country
Italy
City
Milano
ZIP/Postal Code
20141
Country
Italy
City
Napoli
ZIP/Postal Code
80131
Country
Italy
City
Palermo
ZIP/Postal Code
90146
Country
Italy
City
Roma
ZIP/Postal Code
00144
Country
Italy
City
Amersfoort
ZIP/Postal Code
3800 BM
Country
Netherlands
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
City
Amsterdam
Country
Netherlands
City
Den Haag
ZIP/Postal Code
2545 CH
Country
Netherlands
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
City
Enschede
ZIP/Postal Code
7511 JX
Country
Netherlands
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
City
Oslo
ZIP/Postal Code
0310
Country
Norway
City
Tromso
ZIP/Postal Code
N-9038
Country
Norway
City
Coimbra
ZIP/Postal Code
3000-076
Country
Portugal
City
Lisboa
ZIP/Postal Code
1070-213
Country
Portugal
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Madrid
ZIP/Postal Code
28007
Country
Spain
City
Madrid
ZIP/Postal Code
28040
Country
Spain
City
Malaga
ZIP/Postal Code
29010
Country
Spain
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
City
Valencia
ZIP/Postal Code
46010
Country
Spain
City
Göteborg
ZIP/Postal Code
41685
Country
Sweden
City
Umeå
ZIP/Postal Code
901 85
Country
Sweden
City
Uppsala
ZIP/Postal Code
S-751 85
Country
Sweden
City
Zürich
State/Province
Bern / 633
ZIP/Postal Code
8091
Country
Switzerland
City
St. Gallen
State/Province
St. Gallen / 633
ZIP/Postal Code
9007
Country
Switzerland
City
Aarau
ZIP/Postal Code
5000
Country
Switzerland
City
Bellinzona
ZIP/Postal Code
6500
Country
Switzerland
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
City
Glasgow
ZIP/Postal Code
G11 6NT
Country
United Kingdom
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
City
London
ZIP/Postal Code
NW3 2PF
Country
United Kingdom
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
City
Newcastle-Upon-Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
City
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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