NCT01874054

Study of Brentuximab Vedotin Combined With Bendamustine in Patients With Hodgkin Lymphoma

A Phase 1/2 Single-arm, Open-label Study to Evaluate the Safety and Efficacy of Brentuximab Vedotin in Combination With Bendamustine in Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Seagen Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess safety and efficacy of brentuximab vedotin in combination with bendamustine in patients with relapsed or refractory Hodgkin lymphoma. It is an open-label, 2-stage study designed to determine the recommended dose level of bendamustine in combination with brentuximab vedotin. The study will assess the safety profile of the combination treatment and determine what proportion of patients achieve a complete remission.

Conditions

• Hodgkin Disease

Interventions

Type	Name	Description
DRUG	brentuximab vedotin	1.8 mg/kg every 3 weeks by intravenous (IV) infusion
DRUG	bendamustine	90 mg/m2 on Days 1 and 2 of 3-week cycles

Timeline

• Start date: 2013-06-01
• Primary completion: 2015-12-01
• Completion: 2018-02-20
• First posted: 2013-06-10
• Last updated: 2019-02-12
• Results posted: 2017-04-06

Locations

13 sites across 1 country: United States