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Brief Title: Study of Veltuzumab and 90Y-Epratuzumab in Relapsed/Refractory, Aggressive NHL
Official Title: Phase I/II Study of Veltuzumab Combined With 90Y-Epratuzumab Tetraxetan in Patients With Relapsed/Refractory, Aggressive Non- Hodgkin's Lymphoma
Study ID: NCT01101581
Brief Summary: The goal of this study is to evaluate a new approach to immunotherapy in NHL by combining two antibodies, veltuzumab and epratuzumab. For treatment, epratuzumab has also been attached to a radioactive isotope called 90yttrium (90Y-epratuzumab). Veltuzumab and 90Y-epratuzumab attack different areas on lymphoma cells. Because of this, treatment with the combination may provide more effective treatment in NHL than either veltuzumab or 90Y-epratuzumab given alone.
Detailed Description: The treatment portion of this study consists of study drug administrations each week for four weeks in a row (a total of 4 treatment days). Patients will then return at intervals up to 12 weeks for blood samples and for evaluations to see if their disease responded and to monitor any adverse effects related to treatment. Some blood tests may then need to be repeated at least a few times and/or until any abnormal findings at earlier evaluations have resolved. Otherwise, patients will continue to be evaluated every 3 months for two years, then every 6 months up to 5 years or until the disease worsens. Participation in the study will end when NHL disease worsens.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Helen F. Graham Cancer Center, Newark, Delaware, United States
MDACC Orlando, Orlando, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Goshen Center for Cancer Care, Goshen, Indiana, United States
Mayo Clinic, Rochester, Minnesota, United States
Weill Med College of Cornell Univ/NYH, New York, New York, United States
University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, United States
Name: William Wegener, MD, PhD
Affiliation: Gilead Sciences
Role: STUDY_CHAIR