Multiple Part Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma Subjects
This trial will study two treatment combinations for classical Hodgkin lymphoma (cHL). This trial will find out if these two treatment combinations work to treat cHL. It will also find out what side effects occur. A side effect is anything the drug does besides treating cancer. This study will have three parts (Parts A, B, and C). The drugs used in Part A are a combination of targeted anticancer drug (brentuximab vedotin) and three chemotherapy drugs (doxorubicin, vinblastine, and dacarbazine). These four drugs are called 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 A+AVD drug combination reduces the number of participants 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. Parts B and C will use drug combination of brentuximab vedotin, plus nivolumab, doxorubicin, and dacarbazine. These four drugs are called AN+AD. Parts B and C will study how well the drugs work to treat cHL and what side effects they cause.
• Treatment-naïve, classic Hodgkin lymphoma (cHL) participants
‣ Participants enrolling in Part A of the study must have Ann Arbor Stage III or IV disease
⁃ Participants enrolling in Part B of the study must have Ann Arbor Stage I or II cH: with bulky mediastinal disease, or Stage III or IV
⁃ Participants enrolling in Part C of the study must have Ann Arbor Stage I or II cHL without bulky disease
• Histologically confirmed cHL according to the current World Health Organization (WHO) Classification
• Bidimensional measurable disease as documented by PET/CT or CT imaging
• Age 12 years or older in the United States. For regions outside of the US, participants must 18 years or older.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2