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

Phase 1 Completed 51 enrolled Seagen Inc. Millennium Pharmaceuticals, Inc. · collab

Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2010-01
Primary completion: 2012-09
Completion: 2012-09

Publications

Results Younes A, Connors JM, Park SI, Fanale M, O'Meara MM, Hunder NN, Huebner D, Ansell SM. Brentuximab vedotin combined with ABVD or AVD for patients with newly diagnosed Hodgkin's lymphoma: a phase 1, open-label, dose-escalation study. Lancet Oncol. 2013 Dec;14(13):1348-56. doi: 10.1016/S1470-2045(13)70501-1. Epub 2013 Nov 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Brentuximab Vedotin	Monoclonal antibody	0.6 mg/kg	Intravenous
Subject	Brentuximab Vedotin	Monoclonal antibody	0.9 mg/kg	Intravenous
Subject	Brentuximab Vedotin	Monoclonal antibody	1.2 mg/kg	Intravenous
Background	Bleomycin	Unknown	10 unknown	Intravenous
Background	Dacarbazine	Small molecule	375 mg/m2	Intravenous
Background	Doxorubicin	Other / unclassified	25 mg/m2	Intravenous
Background	Vinblastine	Small molecule	6 mg/m2	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications