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

Status:	Completed
Conditions:	Lymphoma
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	6/29/2017
Start Date:	February 2011
End Date:	February 28, 2017

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

We found this trial at

sites

M.D. Anderson Cancer Center at University of Texas

Houston, Texas 77030

from

Houston, TX