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

Trial ID or NCT#

NCT01309789

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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
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Investigator(s)

Lauren Maeda
Lauren Maeda
Hematologist, Lymphoma specialist, Hematologist-Oncologist
Clinical Associate Professor, Medicine - Oncology

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Contact

Cancer Clinical Trials Office
650-498-7061

View on ClinicalTrials.gov