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Sponsored by: |
Genzyme |
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Information provided by: | Genzyme |
ClinicalTrials.gov Identifier: | NCT00051701 |
The purpose of this study is to determine the optimal dose of Campath for patients with relapsing or refractory (failed standard therapy) non-Hodgkin's lymphoma. The study will also evaluate the safety of the drug and whether it is effective in treating these patients.
Condition | Intervention | Phase |
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Non-Hodgkins Lymphoma |
Drug: 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 CAMPATH in Patients With Relapsing or Refractory Non-Hodgkin's Lymphoma |
Estimated Enrollment: | 61 |
Study Start Date: | December 2002 |
Estimated Study Completion Date: | June 2005 |
This study is being conducted in 2 parts with the primary objective of part 1 being to determine the maximum tolerated dose (MTD) of CAMPATH (alemtuzumab, MABCAMPATH, CAMPATH) administered intravenously (IV) once a week as treatment for relapsing or refractory non-Hodgkin's lymphoma (NHL). The primary objective of part 2 is to determine the overall response rate (complete response, CR/unconfirmed , plus partial response) of weekly IV CAMPATH in the treatment of relapsing or refractory NHL. This is a Phase I/II study, open-label, multicenter study to evaluate the efficacy and safety of weekly IV CAMPATH as therapy for patients with relapsing or refractory non-Hodgkin's lymphoma.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: Patients must have:
Exclusion Criteria: Patients must not have:
United States, Colorado | |
Aurora, Colorado, United States | |
Colorado Springs, Colorado, United States | |
Denver, Colorado, United States | |
United States, Indiana | |
Indianapolis, Indiana, United States | |
United States, Kansas | |
Overland Park, Kansas, United States | |
United States, Minnesota | |
Minneapolis, Minnesota, United States | |
United States, Missouri | |
Kansas City, Missouri, United States | |
United States, New Mexico | |
Santa Fe, New Mexico, United States | |
United States, Ohio | |
Dayton, Ohio, United States | |
United States, Oklahoma | |
Tulsa, Oklahoma, United States | |
United States, Texas | |
Dallas, Texas, United States | |
Ft. Worth, Texas, United States | |
Plano, Texas, United States | |
San Antonio, Texas, United States | |
Tyler, Texas, United States | |
United States, Washington | |
Spokane, Washington, United States | |
Vancouver, Washington, United States |
Study ID Numbers: | CAM.NHL232, BLA 99-0786 |
Study First Received: | January 15, 2003 |
Last Updated: | June 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00051701 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Non-Hodgkins lymphoma NHL Campath alemtuzumab |
Lymphoma, Small Cleaved-cell, Diffuse Lymphatic Diseases Immunoproliferative Disorders 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 |