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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

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ClinicalTrials.gov Identifier: NCT00185393
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : December 1, 2008
Sponsor:
Information provided by:
Bayer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Biological: Zevalin ([90]Y-ibritumomab tiuxetan, BAY86-5128) Other: no treatment Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 414 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2001
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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


Outcome Measures
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Primary Outcome Measures :
  1. Progression free survival [ Time Frame: End of study ]

Secondary Outcome Measures :
  1. Clinical and molecular response rates [ Time Frame: End of study ]
  2. Overall survival [ Time Frame: End of study ]
  3. Quality of Life [ Time Frame: End of study ]
  4. Adverse events / Toxicity Grading [ Time Frame: Continous ]
  5. Clinical laboratory results [ Time Frame: 3 monthly ]
  6. Vital signs / physical examination [ Time Frame: 3 monthly ]
  7. ECG [ Time Frame: End of study ]
  8. Co-medication [ Time Frame: Continous ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00185393


Locations
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Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Responsible Party: Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00185393    
Other Study ID Numbers: 90966
304820
NHL FIT
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: December 1, 2008
Last Verified: November 2008
Keywords provided by Bayer:
Follicular Non Hodgkin lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases