Overview

A Phase 1 Study of Brentuximab Vedotin Given Sequentially and Combined With Multi-Agent Chemotherapy for CD30-Positive Mature T-Cell and NK-Cell Neoplasms

Status:
Completed
Trial end date:
2017-02-28
Target enrollment:
Participant gender:
Summary
The purpose of this study is to assess the safety profile of brentuximab vedotin sequentially and in combination with multi-agent chemotherapy in front-line treatment for CD30-positive mature T-cell and NK-cell neoplasms, including systemic anaplastic large cell lymphoma. It is a phase 1, open-label, dose escalation study in three arms designed to define the MTD, PK, immunogenicity, and anti-tumor activity of brentuximab vedotin in sequence and in combination with multi-agent front-line chemotherapy.
Phase:
Phase 1
Details
Lead Sponsor:
Seagen Inc.
Seattle Genetics, Inc.
Collaborator:
Millennium Pharmaceuticals, Inc.
Treatments:
Antibodies
Antibodies, Monoclonal
Brentuximab Vedotin
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Prednisone
Vincristine