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

A Phase 1 Study of Brentuximab Vedotin Administered Sequentially and Concurrently With Multi-Agent Chemotherapy as Front-Line Therapy in Patients With CD30-Positive Mature T-Cell and NK-Cell Neoplasms, Including Systemic Anaplastic Large Cell Lymphoma

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.

Inclusion Criteria:

• Treatment-naive CD30-positive mature T-cell and NK-cell neoplasms, including systemic anaplastic large cell lymphoma
• Measurable disease of at least 1.5 cm
• ECOG performance status less than or equal to 2

Exclusion Criteria:

• Known cerebral/meningeal disease, including history of progressive multifocal leukoencephalopathy
• Current diagnosis of primary cutaneous anaplastic large cell lymphoma, mycosis fungoides, Sezary syndrome or other primary cutaneous lymphomas; extranodal NK/T-cell lymphoma, nasal type
• History of another primary malignancy that has not been in remission for at least 3 years
• Left ventricular ejection fraction <45% or symptomatic cardiac disease, or myocardial infarction within the past 12 months
• Viral, bacterial, or fungal infection within two weeks prior to the first dose of brentuximab vedotin
• Known human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus positive status