Clinical Trials & Research

SGN-35-005
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of SGN-35 (brentuximab vedotin) and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Patients at High Risk of Residual Hodgkin Lymphoma (HL) Following Autologous Stem Cell Transplant (ASCT)


Study Design

This is a randomized, double-blind, placebo-controlled, multicenter, Phase 3 clinical trial designed to evaluate the efficacy and safety of SGN-35 and BSC compared to placebo and BSC in the treatment of residual HL following ASCT. Patients will be randomized in a 1:1 manner to receive study treatment (SGN-35 or placebo), administered as a single outpatient IV infusion on Day 1 of each 21-day cycle. Patients will receive a maximum of 16 cycles.


Population

• Patients with HL who have received ASCT in the previous 30-45 days
• Patients at high risk of residual HL post-ASCT as indicated by at least one of the following criteria:

    • History of refractory HL (defined as patients progressing on or failing to achieve a complete remission following frontline standard chemotherapy or a combined modality treatment program)
    • Relapsed or progressive HL that occurs <12 months from the end of frontline standard chemotherapy or a combined modality treatment program
    • Extranodal involvement at the time of pre-ASCT relapse (including extranodal extension of  nodal masses into adjacent vital organs)

 

  • Histologically-confirmed classical HL, which excludes NLPHL
  • Patients who were determined to have a best clinical response of progressive disease with salvage treatment immediately prior to ASCT are EXCLUDED
  • Patients previously treated with SGN-35 are EXCLUDED
  • Patients who previously received an allogeneic transplant are EXCLUDED

 

This research study has been reviewed and is approved by the Temple University Institutional Review Board and is assigned IRB Protocol #13419.


For more information, please call 215-214-3122.