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Sponsored by: |
Genzyme |
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Information provided by: | Genzyme |
ClinicalTrials.gov Identifier: | NCT00077961 |
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.
Condition | Intervention | Phase |
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Non-Hodgkin's Lymphoma |
Drug: CAMPATH (alemtuzumab) |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Study of Rituximab Plus CAMPATH in Patients With Previously Treated Relapsed or Refractory Low-Grade Follicular, CD20-positive, B-cell Non-Hodgkin's Lymphoma |
Estimated Enrollment: | 49 |
Study Start Date: | December 2003 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Colorado | |
Colorado Springs, Colorado, United States, 80909 | |
United States, Florida | |
Ocala, Florida, United States, 34474 | |
United States, Illinois | |
Park Ridge, Illinois, United States, 60068 | |
United States, Louisiana | |
Lafayette, Louisiana, United States, 70506 | |
New Orleans, Louisiana, United States, 70115 | |
United States, Missouri | |
Columbia, Missouri, United States, 65201 | |
United States, New York | |
Manhasset, New York, United States, 11030 | |
United States, North Carolina | |
Cary, North Carolina, United States, 27511 | |
United States, Ohio | |
Canton, Ohio, United States, 44718 | |
United States, South Carolina | |
Greenville, South Carolina, United States, 29615 |
Study Director: | Medical Monitor | Genzyme |
Responsible Party: | Genzyme Corporation ( Medical Monitor ) |
Study ID Numbers: | CAM.NHL233 |
Study First Received: | February 13, 2004 |
Last Updated: | July 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00077961 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Non-Hodgkin's Lymphoma NHL CAMPATH alemtuzumab |
Lymphoma, Small Cleaved-cell, Diffuse Lymphoma, B-Cell Lymphatic Diseases Immunoproliferative Disorders B-cell Lymphomas |
Rituximab Alemtuzumab Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Alemtuzumab Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Pharmacologic Actions |