NCT02423291

Study Title
A Study of SGN-35 (Brentuximab Vedotin) of Patients With Relapsed or Refractory PMLBCL (FIL_SGN01) (NCT02423291)

Trial Description
Study Objectives Primary:

  • To determine the antitumor efficacy of single-agent brentuximab vedotin/SGN-035 (1.8 mg/kg administered intravenously every 3 weeks) as measured by the overall objective response rate in patients with relapsed or refractory primary mediastinal large B-cell lymphoma.

Secondary:

  • To assess duration of tumor control, including duration of response and progression-free survival
  • To assess survival
  • To assess the safety and tolerability of brentuximab vedotin

Additional:

  • To assess disease-related symptoms

Number of Planned Patients 20 patients will be enrolled in this study. Duration of the study The study duration is 18 months for enrollment and 2 years for the follow-up.

This study is sponsored by Fondazione Italiana Linfomi ONLUS [1]

Study Data

  • Condition: Lymphoma
  • Interventions:
  • Phase: II
  • Estimated Enrollment: 20
  • Start: October 2013
  • Estimated Completion: December 2018
  • Last verified: April 2015

Study Schematic

(Coming soon)

Last Editorial review: July 6, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.