NCT01421667

A Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma

A Phase 2 Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma (NHL)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 176 (actual)
• Sponsor: Seagen Inc. · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter, phase 2 clinical trial to evaluate the efficacy and safety of brentuximab vedotin as a single agent in patients with CD30-positive non-Hodgkin lymphoma (NHL) (Part A). The study will also evaluate the safety and efficacy of brentuximab vedotin in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (Part B) as well as further evaluate correlation of CD30 expression and response in DLBCL (Part C).

Conditions

• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Non-Hodgkin
• Lymphoma, T-Cell

Interventions

Type	Name	Description
DRUG	brentuximab vedotin	1.8 mg/kg every 3 weeks by IV infusion
DRUG	rituximab	375 mg/m2 every 3 weeks by IV infusion

Timeline

• Start date: 2011-08-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2011-08-23
• Last updated: 2016-11-28
• Results posted: 2016-10-13

Locations

34 sites across 2 countries: United States, Canada