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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Lymphoma, Non-Hodgkin

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression free survival

Outcome Time Frame:

End of study

Safety Issue:

No

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

European Union: European Medicines Agency

Study ID:

90966

NCT ID:

NCT00185393

Start Date:

August 2001

Completion Date:

February 2007

Related Keywords:

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

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