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Sponsored by: |
Biogen Idec |
Information provided by: | Biogen Idec |
ClinicalTrials.gov Identifier: | NCT00103558 |
This is an open label, Phase I/II, dose escalation research study of an investigational product called lumiliximab, given with FDA (Food and Drug Administration) approved products fludarabine, cyclophosphamide, and rituximab (FCR). The study duration is 17 visits over 42 months or until your disease progresses and you require additional CLL therapy. The total duration of participation in the study will be approximately 4 years, however your disease status will be followed indefinitely (forever).
Condition | Intervention | Phase |
Chronic Lymphocytic Leukemia |
Drug: Lumiliximab with FCR |
Phase I Phase II |
MedlinePlus related topics: | Leukemia, Adult Acute Leukemia, Adult Chronic |
ChemIDplus related topics: | Cyclophosphamide Fludarabine Fludarabine monophosphate Rituximab Lumiliximab |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Study of Lumiliximab in Combination With Fludarabine, Cyclophosphamide, and Rituximab in Subjects With Relapsed Chronic Lymphocytic Leukemia |
Enrollment: | 31 |
Study Start Date: | March 2004 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |||||
Research Site | |||||
Birmingham, Alabama, United States | |||||
United States, California | |||||
Research Site | |||||
San Diego, California, United States | |||||
United States, Maryland | |||||
Research Site | |||||
Baltimore, Maryland, United States | |||||
United States, Ohio | |||||
Research Site | |||||
Columbus, Ohio, United States | |||||
United States, Texas | |||||
Research Site | |||||
Houston, Texas, United States |
Biogen Idec |
Responsible Party: | Biogen Idec ( Biogen Idec MD ) |
Study ID Numbers: | 152-30 |
First Received: | February 10, 2005 |
Last Updated: | April 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00103558 |
Health Authority: | United States: Food and Drug Administration |
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