Study for Newly Diagnosed Follicular Lymphoma Patients With a Large Tumor Burden
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00136552 |
Recruitment Status :
Completed
First Posted : August 29, 2005
Last Update Posted : July 3, 2007
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Sponsor:
Lymphoma Study Association
Information provided by:
Lymphoma Study Association
Tracking Information | ||||
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First Submitted Date ICMJE | August 25, 2005 | |||
First Posted Date ICMJE | August 29, 2005 | |||
Last Update Posted Date | July 3, 2007 | |||
Study Start Date ICMJE | May 2000 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures ICMJE |
Event free survival | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Response rate, overall survival | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Study for Newly Diagnosed Follicular Lymphoma Patients With a Large Tumor Burden | |||
Official Title ICMJE | FL-2000 Study for Newly Diagnosed Follicular Lymphoma Patients With a High Tumor Burden | |||
Brief Summary | The purpose of this study is to assess in a prospective multicentric study (Phase III) the introduction of a monoclonal antibody directed against B-cells associated with a standard therapy including chemotherapy and alpha-interferon in first line treatment of patients with a large tumor burden follicular lymphoma. | |||
Detailed Description | Follicular lymphoma patients with a large tumor burden will be randomized for 18 months of treatment with either:
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Lymphoma | |||
Intervention ICMJE | Drug: rituximab | |||
Study Arms ICMJE | Not Provided | |||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE |
360 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date ICMJE | December 2004 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium, France | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00136552 | |||
Other Study ID Numbers ICMJE | FL2000 PHRC |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Lymphoma Study Association | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Lymphoma Study Association | |||
Verification Date | July 2007 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |