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| Tracking Information | |||||
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| First Received Date ICMJE | October 3, 2006 | ||||
| Last Updated Date | September 23, 2008 | ||||
| Start Date ICMJE | October 2006 | ||||
| Estimated Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Safety [ Time Frame: 18 months ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
Progression-free survival is the primary outcome | ||||
| Change History | Complete list of historical versions of study NCT00384111 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Safety [ Time Frame: 18 months ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE |
Secondary outcome measures would include characterizing the safety profile | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Phase 3 Study of Zevalin Following R-CVP in Previously Untreated Patients With Follicular NHL | ||||
| Official Title ICMJE | A Phase 3, Open-Label, Multicenter, Randomized Study to Compare the Efficacy and Safety of the Zevalin (Ibritumomab Tiuxetan) Therapeutic Regimen Following Cyclophosphamide, Vincristine, Prednisone, and Rituximab (R CVP) With R CVP Alone in High Risk Subjects With Previously Untreated CD20 Positive Follicular Non Hodgkin's Lymphoma | ||||
| Brief Summary | This study will treat follicular lymphoma patients who have not received previous treatment with R-CVP. Half of the patients will receive Zevalin after R-CVP and the other half will receive only R-CVP. The two patient groups will be compared to determine if Zevalin given after R-CVP therapy provides greater benefits than receiving no additional anti-cancer therapy after R-CVP. |
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| Detailed Description | |||||
| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Allocation: Randomized Control: Active Control Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 26 | ||||
| Estimated Completion Date | March 2010 | ||||
| Estimated Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00384111 | ||||
| Responsible Party | Igor Gorbatchevsky, M.D., Cell Therapeutics, Inc | ||||
| Study ID Numbers ICMJE | 106NH301 | ||||
| Study Sponsor ICMJE | Cell Therapeutics | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Cell Therapeutics | ||||
| Verification Date | September 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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