NCT01060904

A Phase 1 Study of Brentuximab Vedotin Combined With Multi-Agent Chemotherapy for Hodgkin Lymphoma

A Phase 1 Dose-Escalation Safety Study of Brentuximab Vedotin in Combination With Multi-Agent Chemotherapy as Frontline Therapy in Patients With Hodgkin Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Seagen Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety profile of brentuximab vedotin in combination with multi-agent chemotherapy in treatment-naive Stage IIa or IIb-IV Hodgkin lymphoma. It is a phase 1, two-arm, open-label dose escalation study designed to define the maximum tolerated dose, pharmacokinetics, immunogenicity and anti-tumor activity of brentuximab vedotin in combination with frontline therapy.

Conditions

• Disease, Hodgkin

Interventions

Type	Name	Description
DRUG	brentuximab vedotin	0.6-1.2 mg/kg IV every 2 weeks
DRUG	doxorubicin	25 mg/m2 IV every 2 weeks
DRUG	vinblastine	6 mg/m2 IV every 2 weeks
DRUG	dacarbazine	375 mg/m2 IV every 2 weeks
DRUG	bleomycin	10 units/m2 IV every 2 weeks
DRUG	brentuximab vedotin	0.9-1.2 mg/kg IV every 2 weeks

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2010-02-02
• Last updated: 2014-12-18

Locations

4 sites across 2 countries: United States, Canada