SCCA Lymphoma Clinical Trials

The purpose of this study is to provide the option of brentuximab vedotin treatment to patients randomly allocated to placebo treatment in the Phase 3 study SGN35-005 that experienced disease progression of HL. Additionally in the US only, the purpose of this study is to provide access to brentuximab vedotin for patients with relapsed or refractory HL who have previously received an autologous SCT or patients with relapsed or refractory systemic ALCL who have previously failed frontline chemotherapy.

What is Expanded Access? Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial. Read more about expanded access.

• Participated in the placebo arm of the SGN35-005 clinical study and experienced disease progression of HL as defined by the SGN35-005 study protocol. Or in the US only: Patients with relapsed or refractory HL who have previously received an autologous SCT or patients with relapsed or refractory systemic ALCL who have previously failed frontline chemotherapy.
• Completed any previous treatment with radiation, chemotherapy, biologics and/or investigational agents at least 4 weeks prior to the first dose of brentuximab vedotin

• History of another primary malignancy that has not been in remission for at least 3 years
• Known cerebral/meningeal disease
• Peripheral neuropathy of grade 2 or greater
• Females who are pregnant or lactating
• Patients who are eligible to participate in other brentuximab vedotin clinical studies