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)
Trial ID or NCT#
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).
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
- - Patients with HL who have received ASCT in the previous 30-45 days - Patients at high risk of residual HL post ASCT - Histologically-confirmed HL - ECOG of 0 or 1 - Adequate organ function
- - Previous treatment with brentuximab vedotin - Previously received an allogeneic transplant - Patients who were determined to have a best clinical response of progressive disease with salvage treatment immediately prior to ASCT - History of another primary malignancy that has not been in remission for at least 3 years - Post ASCT or current therapy with other systemic anti-neoplastic or investigational agents
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