NCT01100502

A Phase 3 Study of Brentuximab Vedotin (SGN-35) in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant (The AETHERA Trial)

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of SGN-35 and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Patients at High Risk of Residual Hodgkin Lymphoma Following Autologous Stem Cell Transplant

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 329 (actual)
• Sponsor: Seagen Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Disease, Hodgkin

Interventions

Type	Name	Description
DRUG	brentuximab vedotin	Every 21 days by IV infusion (1.8 mg/kg)
DRUG	placebo	Every 21 days by IV infusion

Timeline

• Start date: 2010-04-30
• Primary completion: 2014-08-31
• Completion: 2020-04-27
• First posted: 2010-04-09
• Last updated: 2021-05-14
• Results posted: 2015-11-11

Locations

87 sites across 13 countries: United States, Bulgaria, Czechia, France, Germany, Hungary, Italy, Poland, Romania, Russia, Serbia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study