A Phase II Study of Brentuximab Vedotin with Chemotherapy and Immunotherapy in People with Classical Hodgkin Lymphoma

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Full Title

Multiple Part Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma Subjects

Purpose

The most common treatment for Hodgkin lymphoma is a combination of chemotherapy drugs called ABVD (Adriamycin [doxorubicin], bleomycin, vinblastine, and dacarbazine), sometimes given with radiation therapy. In this study, researchers are assessing the safety and effectiveness of an innovative treatment substituting brentuximab vedotin and the immunotherapy drug nivolumab for bleomycin and vinblastine, without radiation therapy, in people with classical Hodgkin lymphoma who have not yet received any treatment for their disease.

Patients in this study will receive brentuximab vedotin, nivolumab, doxorubicin, and dacarbazine. The goal of the study is to provide optimal treatment to newly diagnosed patients with early-stage disease with the intent to cure, while decreasing side effects and the risk of long-term toxicities.

Brentuximab vedotin 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. Nivolumab takes the brakes off the immune response by inhibiting a protein called PD-1, boosting the ability of the immune system to detect and destroy cancer cells. Brentuximab vedotin and nivolumab are given intravenously (by vein) and doxorubicin and dacarbazine are given as injections.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have stage I or II classical Hodgkin lymphoma without bulky disease in the mediastinum (chest).
  • Patients may not have received prior treatment for their cancer.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 12 and older.

For more information about this study and to inquire about eligibility, please contact Dr. David Straus at 646-608-3702.

Protocol

21-160

Phase

II

Investigator