Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma

Summary

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.

Timeline

Start

2019-01-28

Primary completion

2022-11-07

Completion

2024-08-23

Outcome

Outcome not reported

Stopped: “The study was prematurely discontinued as the sponsor believes the data collected is enough to show the safety and efficacy of the combinations studied in all cohorts. The decision was not based on any safety and/or efficacy concerns.”

Publications

• Abramson JS, Straus DJ, Bartlett NL, Burke JM, Lynch RC, Domingo Domenech E, Hess B, Schuster SR, Linhares Y, Gandhi M, Shah HR, Jurczak W, Re A, Hahn U, Prince HM, Guo W, Davis G, Ho L, Fanale M, Yasenchak CA, Lee HJ. Study of brentuximab vedotin combination treatment in people with early-stage Hodgkin lymphoma: a plain language summary. Future Oncol. 2026 Jul 6:1-14. doi: 10.1080/14796694.2026.2693614. Online ahead of print.
• Abramson JS, Straus DJ, Bartlett NL, Burke JM, Lynch RC, Domingo Domenech E, Hess B, Schuster SR, Linhares Y, Gandhi M, Shah HR, Jurczak W, Re A, Hahn U, Prince HM, Guo W, Davis G, Ho L, Fanale M, Yasenchak CA, Lee HJ. Brentuximab vedotin and nivolumab in combination with chemotherapy for nonbulky, early-stage classical Hodgkin lymphoma. Blood. 2026 Apr 9;147(15):1713-1722. doi: 10.1182/blood.2025030190.
• Lee HJ, Ramchandren R, Friedman J, Melear J, Flinn IW, Burke JM, Linhares Y, Gonzales P, Peterson M, Raval M, Chintapatla R, Feldman TA, Yimer H, Islas-Ohlmayer M, Patel A, Metheny L, Dean A, Rana V, Gandhi MD, Renshaw J, Ho L, Fanale MA, Guo W, Yasenchak CA. Brentuximab vedotin, nivolumab, doxorubicin, and dacarbazine for advanced-stage classical Hodgkin lymphoma. Blood. 2025 Jan 16;145(3):290-299. doi: 10.1182/blood.2024024681.

Drugs

Indications