A Study of SGN-35 (Brentuximab Vedotin) of Patients With Relapsed or Refractory PMLBCL (FIL_SGN01) (NCT02423291)
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.
- 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
- 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 
- Condition: Lymphoma
- Phase: II
- Estimated Enrollment: 20
- Start: October 2013
- Estimated Completion: December 2018
- Last verified: April 2015
Last Editorial review: July 6, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.