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

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.

Conditions

• Lymphoma, Large-Cell, Anaplastic
• Lymphoma, NK-cell
• Lymphoma, T-cell

Interventions

DRUG

brentuximab vedotin

1.2-1.8 mg/kg IV every 3 weeks (Cycles 1-2 and if response, Cycles 9-16)

DRUG

cyclophosphamide

750 mg/m2 IV every 3 weeks (Cycles 3-8)

DRUG

brentuximab vedotin

1.2-1.8 mg/kg IV every 3 weeks (Cycles 1-6 and if response, Cycles 7-16)

DRUG

prednisone

100 mg daily PO on Days 1-5 every 3 weeks (Cycles 3-8)

DRUG

cyclophosphamide

750 mg/m2 IV every 3 weeks (Cycles 1-6)

DRUG

doxorubicin

50 mg/m2 IV every 3 weeks (Cycles 3-8)

DRUG

doxorubicin

50 mg/m2 IV every 3 weeks (Cycles 1-6)

DRUG

prednisone

100 mg daily PO on Days 1-5 every 3 weeks (Cycles 1-6)

DRUG

vincristine

1.4 mg/m2 IV every 3 weeks (Cycles 3-8)

Sponsors & Collaborators

• Millennium Pharmaceuticals, Inc.

  collaborator INDUSTRY

• Seagen Inc.

  lead INDUSTRY

Principal Investigators

• Dana Kennedy, PharmD, BCOP · Seagen Inc.

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-02-28

Primary Completion

2013-04-30

Completion

2017-02-28

Countries

• United States
• United Kingdom

Study Locations