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, HodgkinAntigens, CD30Antibody-Drug ConjugateAntibodies, MonoclonalDrug TherapyHematologic DiseasesImmunotherapyLymphomaMonomethylauristatin EHodgkin DiseaseAntibodiesbrentuximab 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 FranciscoCalifornia94134United States
  • Stanford Cancer Center
    StanfordCalifornia94305United States

Lead Scientist

  • Weiyun Ai
    Authored (or co-authored) 40 research publications

Details

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