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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
Est. primary completion date
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


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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