Conditions: Disease, Hodgkin
Keywords: Antigens, CD30 Antibody-Drug Conjugate Antibodies, Monoclonal Disease, Hodgkin Drug Therapy Hematologic Diseases Immunotherapy Lymphoma Monomethylauristatin E
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 329
Healthy volunteers: no

Brief summary:
This is a randomized, double-blind, placebo-controlled, multicenter phase 3 trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) and best supportive care (BSC) compared to placebo and BSC in treatment of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT).

Detailed description:

Arms:
arm 1: brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion arm 2: placebo every 3 weeks by IV infusion

Interventions: intervention 1: brentuximab vedotin intervention 2: placebo
Intervention descriptions: intervention 1: Every 21 days by IV infusion (1.8 mg/kg) intervention 2: Every 21 days by IV infusion

Protocol document: