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 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) |