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

Not Recruiting

Trial ID: NCT01309789

Purpose

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.

Official Title

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

Stanford Investigator(s)

Lauren Maeda
Lauren Maeda

Clinical Associate Professor, Medicine - Oncology

Eligibility

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

Intervention(s):

drug: Brentuximab Vedotin

drug: cyclophosphamide

drug: prednisone

drug: cyclophosphamide

drug: doxorubicin

drug: doxorubicin

drug: prednisone

drug: vincristine

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061

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