Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma

Exclusion Criteria

• •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