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Brief Title: 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
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
Study ID: NCT01309789
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:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
St. Francis Hospital, Greenville, South Carolina, United States
MD Anderson Cancer Center / University of Texas, Houston, Texas, United States
Seattle Cancer Care Alliance / University of Washington Medical Center, Seattle, Washington, United States
Christie Hospital NHS Foundation Trust, Manchester, , United Kingdom
Southampton General Hospital, Southampton, , United Kingdom
Name: Dana Kennedy, PharmD, BCOP
Affiliation: Seagen Inc.
Role: STUDY_DIRECTOR