Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma

Stopped early · Phase 2

Conditions studied: Hodgkin Lymphoma

In brief

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.

Key facts

Study ID

NCT03646123

Run by

Seagen Inc.

People needed

255

Starts

2019-01-28

Expected to finish

2024-08-23

Last updated by the study team

2025-08-28

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Nodular lymphocyte predominant HL
• 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
• Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy within 4 weeks of the first study drug dose
• 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
• Active cerebral/meningeal disease related to the underlying malignancy
• 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)
• Current therapy with other systemic anti-neoplastic or investigational agents
• Planned consolidative radiotherapy (Parts B and C only)
• 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)
• Grade 3 or higher pulmonary disease unrelated to underlying malignancy
• Documented history of idiopathic interstitial pneumonia or diffusing capacity of the lung for carbon monoxide <50% predicted
• History of a cerebral vascular event within 6 months of first dose of study drug
• Child-Pugh B or C hepatic impairment
• Grade 2 or higher peripheral sensory or motor neuropathy
• Participants with acute or chronic graft-versus-host-disease (GvHD) or receiving immunosuppressive therapy as treatment or as prophylaxis against GvHD
• Previous treatment with brentuximab vedotin
• Participants who are pregnant or breastfeeding
• Other serious condition that would impair the participant's ability to receive or tolerate the planned treatment and follow-up

Where it is running

• Rocky Mountain Cancer Centers - Aurora — Aurora, Colorado, United States
• University of Colorado Health Memorial Hospital — Colorado Springs, Colorado, United States
• Cancer Centers of Colorado - Denver — Denver, Colorado, United States
• Poudre Valley Health System (PVHS) — Fort Collins, Colorado, United States
• SCL Health - St. Mary's Hospital & Medical Center — Grand Junction, Colorado, United States
• Miami Cancer Institute at Baptist Health, Inc. — Miami, Florida, United States
• Florida Cancer Specialists - North Region — St. Petersburg, Florida, United States
• Cardinal Bernardin Cancer Center / Loyola University Medical Center — Maywood, Illinois, United States
• Illinois Cancer Specialists — Niles, Illinois, United States
• Illinois Cancer Care — Peoria, Illinois, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Karmanos Cancer Institute / Wayne State University — Detroit, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Minnesota Oncology Hematology P.A. — Edina, Minnesota, United States
• Washington University in St Louis — St Louis, Missouri, United States
• New Jersey Hematology Oncology Associates, LLC — Brick, New Jersey, United States
• Regional Cancer Care Associates - Freehold — Freehold, New Jersey, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Regional Cancer Care Associates - Howell — Howell Township, New Jersey, United States
• Morristown Medical Center/ Carol G. Simon Cancer Center — Morristown, New Jersey, United States
• Regional Cancer Care Associates - Mount Holly — Mount Holly, New Jersey, United States
• Regional Cancer Care Associates - Central Jersey — Somerville, New Jersey, United States
• Regional Cancer Care Associates - Sparta — Sparta, New Jersey, United States
• Los Angeles Cancer Network / Compassionate Care Research Group — Fountain Valley, California, United States

Full record on ClinicalTrials.gov

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