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

Lymphoma, Non-Hodgkin Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00185393
• Other study ID #: 90966
• Secondary ID: 304820NHL FIT
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: November 26, 2008
• Start date: August 2001
• Est. completion date: February 2007

Study information

• Verified date: November 2008
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Paul-Ehrlich-InstitutSpain: Ministry of HealthSwitzerland: SwissmedicGermany: Ministry of HealthNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Italy: Ministry of HealthCanada: Health CanadaUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyNorway: Norwegian Social Science Data ServicesDenmark: Danish Dataprotection AgencyPortugal: National Pharmacy and Medicines Institute
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 414
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular
• Lymphoma, Non-Hodgkin

Intervention

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

Other:
• no treatment
no treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Belgium,  Canada,  Denmark,  France,  Germany,  Italy,  Netherlands,  Norway,  Portugal,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		End of study	No
Secondary	Clinical and molecular response rates		End of study	No
Secondary	Overall survival		End of study	No
Secondary	Quality of Life		End of study	No
Secondary	Adverse events / Toxicity Grading		Continous	Yes
Secondary	Clinical laboratory results		3 monthly	Yes
Secondary	Vital signs / physical examination		3 monthly	Yes
Secondary	ECG		End of study	Yes
Secondary	Co-medication		Continous	Yes

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