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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Brentuximab Vedotin | Monoclonal antibody | 1.2 mg/kg | Intravenous |
| Subject | Dacarbazine | Small molecule | 375 mg/m2 | Intravenous |
| Subject | Doxorubicin | Other / unclassified | 25 mg/m2 | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 240 mg | Intravenous |
| Subject | Vinblastine | Small molecule | 6 mg/m2 | Intravenous |
| Background | Pegfilgrastim | Protein / enzyme biologic | — | — |
| Background | filgrastim | Protein / enzyme biologic | — | — |