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 - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00185393

Purpose

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	Intervention	Phase
Lymphoma, Non-Hodgkin	Biological: Zevalin ([90]Y-ibritumomab tiuxetan, BAY86-5128) Other: no treatment	Phase III

MedlinePlus related topics: Lymphoma

Drug Information available for: Tositumomab Immunoglobulins Globulin, Immune Ibritumomab tiuxetan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Bayer:

Primary Outcome Measures:

Progression free survival [ Time Frame: End of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical and molecular response rates [ Time Frame: End of study ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: End of study ] [ Designated as safety issue: No ]
Quality of Life [ Time Frame: End of study ] [ Designated as safety issue: No ]
Adverse events / Toxicity Grading [ Time Frame: Continous ] [ Designated as safety issue: Yes ]
Clinical laboratory results [ Time Frame: 3 monthly ] [ Designated as safety issue: Yes ]
Vital signs / physical examination [ Time Frame: 3 monthly ] [ Designated as safety issue: Yes ]
ECG [ Time Frame: End of study ] [ Designated as safety issue: Yes ]
Co-medication [ Time Frame: Continous ] [ Designated as safety issue: Yes ]

Enrollment:	414
Study Start Date:	August 2001
Study Completion Date:	February 2007

Arms	Assigned Interventions
Arm 1: Experimental	Biological: Zevalin ([90]Y-ibritumomab tiuxetan, BAY86-5128) treatment with 90 Yttrium-labeled anti CD 20 antibody
Arm 2	Other: no treatment no 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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185393

Show 95 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

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Responsible Party:	Bayer Schering Pharma AG ( Therapeutic Area Head )
Study ID Numbers:	90966, 304820, NHL FIT
Study First Received:	September 12, 2005
Last Updated:	November 26, 2008
ClinicalTrials.gov Identifier:	NCT00185393
Health Authority:	European Union: European Medicines Agency; France: Afssaps - French Health Products Safety Agency; Germany: Paul-Ehrlich-Institut; Spain: Ministry of Health; Switzerland: Swissmedic; Germany: Ministry of Health; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Italy: Ministry of Health; Canada: Health Canada; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Norway: Norwegian Social Science Data Services; Denmark: Danish Dataprotection Agency; Portugal: National Pharmacy and Medicines Institute

Keywords provided by Bayer:

Follicular Non Hodgkin lymphoma

Study placed in the following topic categories:

Antibodies, Monoclonal
Lymphatic Diseases
Antibodies
Immunoproliferative Disorders
Lymphoma, small cleaved-cell, diffuse
Lymphoma, Follicular

Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Follicular lymphoma
Immunoglobulins

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immunologic Factors

Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009