At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of SGN-35 (Brentuximab Vedotin) of Patients With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (PMLBCL)
In Brief
A Phase 2 clinical trial evaluating Brentuximab Vedotin for Primary Mediastinal Large B Cell Lymphoma. Completed, enrolled 15 participants across 9 sites.
Detailed Summary
Study Objectives Primary: • To determine the antitumor efficacy of single-agent Brentuximab vedotin (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.
Study Details
Timeline
Interventions
Brentuximab vedotin, 1.8 mg/kg, administered via outpatient IV infusion on Day 1 of each 21-day cycle.