TriangleNCT00185393 · CITED IN SOURCE DOCUMENTS
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
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2008-12-01
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
No posted result sections were captured. Registered plans do not establish that a treatment works.
Who could take part
- eligibility 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
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- intervention Names
- Biological: Zevalin ([90]Y-ibritumomab tiuxetan, BAY86-5128)
- label
- Arm 1
- type
- EXPERIMENTAL
- intervention Names
- Other: no treatment
- label
- Arm 2
- type
- OTHER
- interventions
- arm Group Labels
- Arm 1
- description
- treatment with 90 Yttrium-labeled anti CD 20 antibody
- name
- Zevalin ([90]Y-ibritumomab tiuxetan, BAY86-5128)
- type
- BIOLOGICAL
- arm Group Labels
- Arm 2
- description
- no treatment
- name
- no treatment
- type
- OTHER
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 414
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- measure
- Progression free survival
- time Frame
- End of study
- secondary Outcomes
- measure
- Clinical and molecular response rates
- time Frame
- End of study
- measure
- Overall survival
- time Frame
- End of study
- measure
- Quality of Life
- time Frame
- End of study
- measure
- Adverse events / Toxicity Grading
- time Frame
- Continous
- measure
- Clinical laboratory results
- time Frame
- 3 monthly
- measure
- Vital signs / physical examination
- time Frame
- 3 monthly
- measure
- ECG
- time Frame
- End of study
- measure
- Co-medication
- time Frame
- Continous
Full study description
- 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.
- 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.
Source references
Source notices and limitations
Discovery and provenance
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- occurrences
- context exact
- se of 11.6 months (range: 1.0-42.4+ months)]. 14.2 Follicular, B-Cell NHL Upon Completion of First-Line Chemotherapy The FIT (First-line Indolent Trial) study (NCT00185393) was a multi-center, randomized, open-label study conducted in patients with follicular NHL with a partial (PR) or complete response (CR/CRu) upon completion o
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Preserved source evidence · Not medical advice