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.
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
10
sites
UAB Comprehensive Cancer Center One of the nation’s leading cancer research and treatment centers, the...
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1500 East Duarte Road
Duarte, California 91010
Duarte, California 91010
626-256-HOPE (4673)
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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