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Brief Title: Phase I/II Study of CAMPATH in Patients With Relapsing or Refractory Non-Hodgkin's Lymphoma
Official Title: Phase I/II Study of CAMPATH in Patients With Relapsing or Refractory Non-Hodgkin's Lymphoma
Study ID: NCT00051701
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, Aurora, Colorado, United States
, Colorado Springs, Colorado, United States
, Denver, Colorado, United States
, Indianapolis, Indiana, United States
, Overland Park, Kansas, United States
, Minneapolis, Minnesota, United States
, Kansas City, Missouri, United States
, Santa Fe, New Mexico, United States
, Dayton, Ohio, United States
, Tulsa, Oklahoma, United States
, Dallas, Texas, United States
, Ft. Worth, Texas, United States
, Plano, Texas, United States
, San Antonio, Texas, United States
, Tyler, Texas, United States
, Spokane, Washington, United States
, Vancouver, Washington, United States
Name: Medical Monitor
Affiliation: Genzyme, a Sanofi Company
Role: STUDY_DIRECTOR