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
- Conditions
- Lymphoma, Large-Cell, AnaplasticLymphoma, NK-cellLymphoma, T-cell
- Interventions
- Registration Number
- NCT01309789
- Lead Sponsor
- Seagen Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 2 cyclophosphamide Combination 1 brentuximab vedotin Sequential 1 prednisone Sequential 3 Brentuximab vedotin/CH-P cyclophosphamide Combination 1 cyclophosphamide Sequential 1 doxorubicin Sequential 2 prednisone Combination 3 Brentuximab vedotin/CH-P prednisone Combination 2 brentuximab vedotin Combination 2 doxorubicin Combination 3 Brentuximab vedotin/CH-P doxorubicin Combination 1 vincristine Sequential 3 Brentuximab vedotin/CH-P brentuximab vedotin Combination
- Primary Outcome Measures
Name Time Method Incidence of adverse events and laboratory abnormalities Through 1 month after last dose
- Secondary Outcome Measures
Name Time Method Overall survival Every 3 months until death or study closure Brentuximab vedotin concentration in blood Through 1 month after last dose Antitherapeutic antibodies in blood Through 1 month after last dose Best clinical response Through 1 month after last dose Progression-free survival Until disease progression or study closure
Trial Locations
- Locations (11)
UAB Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
City of Hope National Medical Center
🇺🇸Duarte, California, United States
Stanford Cancer Center
🇺🇸Stanford, California, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
MD Anderson Cancer Center / University of Texas
🇺🇸Houston, Texas, United States
Christie Hospital NHS Foundation Trust
🇬🇧Manchester, United Kingdom
Southampton General Hospital
🇬🇧Southampton, United Kingdom
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Seattle Cancer Care Alliance / University of Washington Medical Center
🇺🇸Seattle, Washington, United States
St. Francis Hospital
🇺🇸Greenville, South Carolina, United States