The purpose of this study is to determine the optimal dose of subcutaneous CAMPATH when used in combination with rituximab for patients with relapsing or refractory, low-grade or follicular, CD-20-positive, B-Cell non-Hodgkin's Lymphoma. Safety will be the primary objective of phase I, while the primary objective of phase II will be to determine overall response.
This study is being conducted in 2 parts. Phase I will involve dose escalation of subcutaneous CAMPATH (SQ) given 3 times per week in combination with weekly doses of rituximab (375mg/m2) for a maximum of 8 weeks in order to determine the maximum tolerated dose (MTD). In Phase II patients will be treated with SQ CAMPATH at the MTD plus weekly rituximab (375mg/m2)for a maximum of 8 weeks with primary objective of defining Overall Response (OR) to this combination.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Unnamed facility
Colorado Springs, Colorado, United States
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Ocala, Florida, United States
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Park Ridge, Illinois, United States
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Lafayette, Louisiana, United States
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New Orleans, Louisiana, United States
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Columbia, Missouri, United States
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Manhasset, New York, United States
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Cary, North Carolina, United States
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Canton, Ohio, United States
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Greenville, South Carolina, United States