Sponsor: Seattle Genetics, Inc.
Sponsor Study ID: SGN35-027
Study Title: Multiple Part Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma Subjects
CTO #: 103258
NCT Number: NCT03646123
Phase: II
Protocol Type: Treatment
Age Group: Both
Disease Sites: Hodgkin's Lymphoma
Study Objectives: This trial will study two treatment combinations for classical Hodgkin lymphoma (cHL). This study will have two parts. The drugs used in Part A are a targeted anticancer drug (brentuximab vedotin) and three chemotherapy drugs (doxorubicin, vinblastine, and dacarbazine). These four drugs are referred to as A+AVD. Participants will be treated with granulocyte colony stimulating factor (G-CSF) following every dose of A+AVD for 6 cycles of treatment (12 doses). Part A will look at whether the drug combination reduces the number of patients who experience the side effect of febrile neutropenia. Febrile neutropenia is a very low white blood cell count and a fever, which can be life threatening. Part B will use brentuximab vedotin, plus nivolumab, doxorubicin, and dacarbazine. These four drugs are called AN+AD. Participants will be given these drugs for up to 12 doses (up to 6 months). This part of the trial will look at whether this combination of drugs is safe and effective for treatment of cHL.