Protocol
12-035
Full Title
A Phase 2 Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma (NHL)
Purpose
The purpose of this study is to evaluate the safety and effectiveness of a drug called brentuximab vedotin (SGN-35) in patients with non-Hodgkin lymphoma that has either returned or persists despite prior therapy. It is already approved in the United States for the treatment of systemic anaplastic large cell lymphoma (ALCL) or Hodgkin lymphoma, which both contain high amounts of CD30. However, there are other types of non-Hodgkin lymphoma that contain lower amounts of CD30, and doctors would like to know if brentuximab is effective against these cancers as well.
Brentuximab has two parts: one (an antibody) that attaches to a protein on the surface of cancer cells called CD30, and another (an anticancer drug called monomethyl auristatin E) that kills the cancer.
Investigator
Co-Investigators
Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have CD30-positive non-Hodgkin lymphoma that has either returned or persists despite prior therapy.
- Patients with ALCL may not participate.
- At least 4 weeks must have passed since completion of prior treatment and entry into the study.
- Patients must be able to be ambulatory for more than half of their normal waking hours.
- Patients must be age 12 or older. (Patients ages 6-11 may be eligible to participate with special permission.)
For more information about this study and to inquire about eligibility, please contact Dr. Steven M. Horwitz at 212-639-3045.
Disease(s)
Lymphoma
Lymphoma: Non-Hodgkin's Lymphoma
Locations
ClinicalTrials.gov
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