Safety and Efficacy of IDEC-114 in Combination With Rituxan in the Treatment of Non-Hodgkin's Lymphoma
NCT ID: NCT00048555
Last Updated: 2013-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
90 participants
INTERVENTIONAL
2002-11-30
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
IDEC-114
Dose Group 1 - 125 mg/m2 x 4 infusions \& 375 mg/m2 Rituxan x 4 infusions Dose Group 2 - 250 mg/m2 x 4 infusions \& 375 mg/m2 Rituxan x 4 infusions Dose Group 3 - 375 mg/m2 x 4 infusions \& 375 mg/m2 Rituxan x 4 infusions Dose Group 4 - 500 mg/m2 x 4 infusions \& 375 mg/m2 Rituxan x 4 infusions
Interventions
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IDEC-114
Dose Group 1 - 125 mg/m2 x 4 infusions \& 375 mg/m2 Rituxan x 4 infusions Dose Group 2 - 250 mg/m2 x 4 infusions \& 375 mg/m2 Rituxan x 4 infusions Dose Group 3 - 375 mg/m2 x 4 infusions \& 375 mg/m2 Rituxan x 4 infusions Dose Group 4 - 500 mg/m2 x 4 infusions \& 375 mg/m2 Rituxan x 4 infusions
Eligibility Criteria
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Inclusion Criteria
* Greater than or equal to 18 years of age
* Proof of follicular lymphoma
* Progressive disease requiring treatment after at least 1 prior standard therapy
* Acceptable hematologic status, liver function, and renal function
* Patients of reproductive potential must agree to follow accepted birth control methods during treatment and for 3 months after completion of treatment
Exclusion Criteria
* Presence of CLL or CNS lymphoma
* Known history of HIV infection or AIDS
* Prior diagnosis of aggressive NHL or mantle-cell lymphoma
* Serious nonmalignant disease
* Pregnant or currently breast feeding
18 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Biogen Idec
Locations
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Research site
Birmingham, Alabama, United States
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Tucson, Arizona, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
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San Diego, California, United States
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Aurora, Colorado, United States
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Washington D.C., District of Columbia, United States
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Tampa Bay, Florida, United States
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Chicago, Illinois, United States
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Maywood, Illinois, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Rochester, Minnesota, United States
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Omaha, Nebraska, United States
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Buffalo, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Durham, North Carolina, United States
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Philadelphia, Pennsylvania, United States
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Columbia, South Carolina, United States
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Houston, Texas, United States
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Charlottesville, Virginia, United States
Countries
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References
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Leonard JP, Friedberg JW, Younes A, Fisher D, Gordon LI, Moore J, Czuczman M, Miller T, Stiff P, Cheson BD, Forero-Torres A, Chieffo N, McKinney B, Finucane D, Molina A. A phase I/II study of galiximab (an anti-CD80 monoclonal antibody) in combination with rituximab for relapsed or refractory, follicular lymphoma. Ann Oncol. 2007 Jul;18(7):1216-23. doi: 10.1093/annonc/mdm114. Epub 2007 Apr 29.
Other Identifiers
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114-21
Identifier Type: -
Identifier Source: org_study_id
NCT00056043
Identifier Type: -
Identifier Source: nct_alias