Education and Training
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
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.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: cyclophosphamide
- drug: prednisone
- drug: cyclophosphamide
- drug: doxorubicin
- drug: doxorubicin
- drug: prednisone
- drug: vincristine
- drug: Brentuximab Vedotin
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
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting