Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma

Prior treatment

• Documented history of a cerebral vascular event within 6 months prior to their first dose of brentuximab vedotin
• Subjects with acute or chronic graft-versus-host-disease (GvHD) or receiving immunosuppressive therapy as treatment for or prophylaxis agent against GvHD
• Previous treatment with brentuximab vedotin
• Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy within 4 weeks of 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 Tcell co-stimulation or checkpoint pathways
• Any active Grade 3 or higher (per the National Cancer Institute's Common Terminology Criteria for Adverse Events [NCI CTCAE] Version 4.03) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study drug
• Current therapy with other systemic anti-neoplastic or investigational agents
• Planned consolidative radiotherapy during the study treatment period (Parts B and C only)

Other illness

• Grade 3 or higher pulmonary disease unrelated to underlying malignancy
• Subjects with Child-Pugh B or C hepatic impairment
• History of another malignancy within 3 years before the first dose of study drug or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death. Subjects with nonmelanoma skin cancer, localized prostate cancer, or carcinoma in situ of any type are not excluded if they have undergone complete resection
• Active cerebral/meningeal disease related to the underlying malignancy.
• 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)

Lab values

• Nodular lymphocyte predominant HL

Other

• Idiopathic interstitial pneumonia or diffusing capacity of the lung for carbon monoxide <50% predicted
• Grade 2 or higher peripheral sensory or motor neuropathy at baseline
• Subjects who are pregnant or breastfeeding

• Treatment-naïve, cHL subjects: Subjects enrolling in Part C of the study must have Ann Arbor Stage I or II cHL without bulky mediastinal disease
• Histologically confirmed cHL according to the current World Health Organization 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 United States, subjects must be age 18 years or older
• An Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2