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Clinical trial

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)

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Last updated:13th May 2021
Status: COMPLETED
Identifier: 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)


ClinicalTrials.gov ID: NCT01100502

Sponsor: Seagen Inc.
Information provided by: Seagen Inc. (Responsible Party)
Last Update Posted: 2021-05-14

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).

Official Title:
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 Transplantµ

Intervention / Treatment:
- Drug: brentuximab vedotin
- Drug: placebo

Category Value
Study Start (Actual)
2010-04-30
Primary Completion (Actual) 2014-08-31
Study Completion (Actual) 2020-04-27
Enrollment (Actual) 329
Study Type Interventional
Phase Phase 3
Other Study ID Numbers
SGN35-005

2009-016947-20 (EudraCT Number)


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