For Healthcare Professionals

Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma


About the study

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.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Inclusion Criteria

Treatment-naïve, classic Hodgkin lymphoma (cHL) participants

  1. Participants enrolling in Part A of the study must have Ann Arbor Stage III or IV disease
  2. 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
  3. Participants enrolling in Part C of the study must have Ann Arbor Stage I or II cHL without bulky disease
  4. Histologically confirmed cHL according to the current World Health Organization (WHO) Classification
  5. Bidimensional measurable disease as documented by PET/CT or CT imaging
  6. Age 12 years or older in the United States. For regions outside of the US, participants must 18 years or older.
  7. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2


Exclusion Criteria

  1. Nodular lymphocyte predominant HL
  2. History of another malignancy within 3 years of the first dose of study drug or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk or metastasis or death. Participants with nonmelanoma skin cancer, localized prostate cancer, or carcinoma in situ of any type are not excluded if they have undergone complete resection
  3. Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy within 4 weeks of the first study drug dose
  4. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
  5. Active cerebral/meningeal disease related to the underlying malignancy
  6. Any active Grade 3 or higher viral, bacterial, or fungal infection within two weeks of the first dose of study drug (Grade 3 defined by the National Cancer Institute's Common Terminology Criteria for Adverse Events, NCI CTCAE Version 4.03)
  7. Current therapy with other systemic anti-neoplastic or investigational agents
  8. Planned consolidative radiotherapy (Parts B and C only)
  9. Active interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity (Parts B and C only)
  10. Grade 3 or higher pulmonary disease unrelated to underlying malignancy
  11. Documented history of idiopathic interstitial pneumonia or diffusing capacity of the lung for carbon monoxide <50% predicted
  12. History of a cerebral vascular event within 6 months of first dose of study drug
  13. Child-Pugh B or C hepatic impairment
  14. Grade 2 or higher peripheral sensory or motor neuropathy
  15. Participants with acute or chronic graft-versus-host-disease (GvHD) or receiving immunosuppressive therapy as treatment or as prophylaxis against GvHD
  16. Previous treatment with brentuximab vedotin
  17. Participants who are pregnant or breastfeeding
  18. Other serious condition that would impair the participant's ability to receive or tolerate the planned treatment and follow-up

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Study Locations

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How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Hodgkin Lymphoma

Age (in years)



Phase 2

Participants needed


Est. Completion Date

Jun 7, 2026

Treatment type



Seagen Inc. identifier


Study number


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