Pilot Study of Brentuximab Vedotin in CD30 Positive EBV Positive Diffuse Large B-Cell Lymphomas of the Elderly
Brentuximab vedotin is a type of drug called an antibody drug conjugate (ADC). ADCs usually
have 2 parts; a part that targets cancer cells (the antibody) and a cell killing part (the
chemotherapy). Antibodies are proteins that are part of the immune system. They can stick to
and attack specific targets on cells. The antibody part of brentuximab vedotin sticks to a
target called CD30. CD30 is an important molecule on some cancer cells (including
non-Hodgkin lymphoma) and some normal cells of the immune system. The cell killing part of
brentuximab vedotin is a chemotherapy called monomethyl auristatin E (MMAE). After the
brentuximab vedotin attaches to the CD30 part of the cell, the MMAE enters the cell and
More than 350 people with cancer have already been given brentuximab vedotin in research
studies. These research studies were done to test the safety of different doses of
brentuximab vedotin and to find out if brentuximab vedotin is active against cancer.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response Rate (ORR)
The primary efficacy parameter is objective response rate, defined as the proportion of patients with complete response (CR) and partial response (PR). To evaluate the activity of Brentuximab vedotin in patients with refractory/relapsed EDLBCLE using modified International Working Group (IWG) response criteria for malignant lymphoma. Measurable lesions: Lesions that can be measured accurately in at least one dimension (longest diameter to be recorded) as ≥20 mm with conventional techniques, or as ≥10 mm with spiral CT scan. Nonmeasurable lesions: Lesions not classified as measurable lesions (longest diameter ≤20 mm with conventional techniques or ≤10 mm with spiral CT scan. Frequencies and percentages will be used to summarize for all response categories. The ORR, our primary endpoint, and its 95 confidence interval will be calculated using the exact binominal method.
Lubomir Sokol, M.D., Ph.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|