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

Completed · Phase 1

Conditions studied: Lymphoma, Large-Cell, Anaplastic, Lymphoma, NK-cell, Lymphoma, T-cell

In brief

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.

Key facts

Study ID

NCT01309789

Run by

Seagen Inc.

People needed

39

Starts

2011-02-01

Expected to finish

2017-02-28

Last updated by the study team

2017-06-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UAB Comprehensive Cancer Center — Birmingham, Alabama, United States
• City of Hope National Medical Center — Duarte, California, United States
• Stanford Cancer Center — Stanford, California, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• St. Francis Hospital — Greenville, South Carolina, United States
• MD Anderson Cancer Center / University of Texas — Houston, Texas, United States
• Seattle Cancer Care Alliance / University of Washington Medical Center — Seattle, Washington, United States
• Christie Hospital NHS Foundation Trust — Manchester, United Kingdom
• Southampton General Hospital — Southampton, United Kingdom

Full record on ClinicalTrials.gov

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