This study is in progress, not accepting new patients

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 study on Hodgkin's Lymphoma Lymphoma

Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Weiyun Ai

Description

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 Transplant

Keywords

Disease, Hodgkin Antigens, CD30 Antibody-Drug Conjugate Antibodies, Monoclonal Drug Therapy Hematologic Diseases Immunotherapy Lymphoma Monomethylauristatin E Hodgkin Disease Antibodies brentuximab vedotin

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California at San Francisco
    San Francisco California 94134 United States
  • Stanford Cancer Center
    Stanford California 94305 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Seattle Genetics, Inc.
ID
NCT01100502
Phase
Phase 3
Lead Scientist
Weiyun Ai
Study Type
Interventional
Last Updated
March 13, 2018