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Completed

NCT Number: 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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Antwerp, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zevalin ([90]Y-ibritumomab tiuxetan, BAY86-5128)

Biological

treatment with 90 Yttrium-labeled anti CD 20 antibody

No treatment

Other

no treatment

Primary outcomes

  1. Progression free survival

    Time frame: End of study

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Important dates

Study start
2001
Study completion
2007
First posted
Sep 16, 2005
Registry last updated
Dec 1, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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