An open-label, treatment-option protocol of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma or relapsed or refractory systemic anaplastic large cell lymphoma
The goal of this clinical research study is learn more about the safety of SGN-35 (brentuximab vedotin) in patients who participated in 2009-0851, were on placebo, and whose HL has gotten worse. Another goal of this study is to allow other patients with HL and ALCL whose disease has come back or is not getting better on another treatment, access to brentuximab vedotin.
Treatment Location: N/A
Primary Objectives The primary objectives of this study are • To provide the option of treatment with brentuximab vedotin for those patients allocated to the placebo treatment arm in study SGN35-005 (2009-0851) who experience progression of Hodgkin Lymphoma (HL) • To assess the safety and tolerability of brentuximab vedotin • In the US only, to provide access to brentuximab vedotin for patients with relapsed or refractory HL, and patients with relapsed or refractory anaplastic large cell lymphoma (ALCL). Endpoints The safety endpoints are the type, incidence, severity, seriousness, and study drug relatedness of adverse events (AEs).
IRB Review and Approval Date: 02/08/2011
Recruitment Status: Closed
Projected Accrual: N/A