Clinical trial NCT00185393: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lymphoma, Non-Hodgkin
Keywords: Follicular Non Hodgkin lymphoma
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 414
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Progression free survival
timeFrame: End of study
Secondary outcomes:
measure: Clinical and molecular response rates
timeFrame: End of study
measure: Overall survival
timeFrame: End of study
measure: Quality of Life
timeFrame: End of study
measure: Adverse events / Toxicity Grading
timeFrame: Continous
measure: Clinical laboratory results
timeFrame: 3 monthly
measure: Vital signs / physical examination
timeFrame: 3 monthly
measure: ECG
timeFrame: End of study
measure: Co-medication
timeFrame: Continous
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
city: Brugge
country: Belgium
city: Bruxelles
country: Belgium
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Yvoir
country: Belgium
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Hamilton
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Aarhus
country: Denmark
city: Copenhagen
country: Denmark
city: Rennes
country: France
state: Bretagne
city: Angers Cedex 1
country: France
city: Besancon
country: France
city: Bordeaux
country: France
city: Creteil
country: France
city: Grenoble Cedex 9
country: France
city: Le Mans
country: France
city: Lille
country: France
city: Lyon
country: France
city: Paris Cedex 15
country: France
city: Pierre Benite
country: France
city: Rouen
country: France
city: Strasbourg
country: France
city: Tours
country: France
city: Tübingen
country: Germany
state: Baden-Wuerttemberg
city: Augsburg
country: Germany
state: Bayern
city: München
country: Germany
state: Bayern
city: Göttingen
country: Germany
state: Niedersachsen
city: Münster
country: Germany
state: Nordrhein-Westfalen / 298
city: Hamm
country: Germany
state: Nordrhein-Westfalen / 358
city: Düsseldorf
country: Germany
state: Nordrhein-Westfalen
city: Köln
country: Germany
state: Nordrhein-Westfalen
city: Dresden
country: Germany
state: Sachsen
city: Hamburg
country: Germany
city: Bologna
country: Italy
state: BO
city: San Giovanni Rotondo
country: Italy
state: Foggia
city: Milano
country: Italy
state: MI
city: Milano
country: Italy
state: MI
city: Rozzano
country: Italy
state: MI
city: Pisa
country: Italy
state: PI
city: Torino
country: Italy
state: TO
city: Milano
country: Italy
city: Napoli
country: Italy
city: Palermo
country: Italy
city: Roma
country: Italy
city: Amersfoort
country: Netherlands
city: Amsterdam
country: Netherlands
city: Amsterdam
country: Netherlands
city: Den Haag
country: Netherlands
city: Eindhoven
country: Netherlands
city: Enschede
country: Netherlands
city: Groningen
country: Netherlands
city: Leiden
country: Netherlands
city: Maastricht
country: Netherlands
city: Nijmegen
country: Netherlands
city: Rotterdam
country: Netherlands
city: Utrecht
country: Netherlands
city: Zwolle
country: Netherlands
city: Oslo
country: Norway
city: Tromso
country: Norway
city: Coimbra
country: Portugal
city: Lisboa
country: Portugal
city: Lisboa
country: Portugal
city: Porto
country: Portugal
city: Hospitalet de Llobregat
country: Spain
state: Barcelona
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Salamanca
country: Spain
city: Valencia
country: Spain
city: Göteborg
country: Sweden
city: Umeå
country: Sweden
city: Uppsala
country: Sweden
city: Zürich
country: Switzerland
state: Bern / 633
city: St. Gallen
country: Switzerland
state: St. Gallen / 633
city: Aarau
country: Switzerland
city: Bellinzona
country: Switzerland
city: Bern
country: Switzerland
city: Geneva
country: Switzerland
city: Lausanne
country: Switzerland
city: Glasgow
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Newcastle-Upon-Tyne
country: United Kingdom
city: Plymouth
country: United Kingdom
city: Surrey
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: