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 (NCT01309789)
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 I, open-label, dose escalation study in three arms designed to define the MTD, PK, immunogenicity, and anti-tumor activity of the antibody-drug conjugate brentuximab vedotin in sequence and in combination with multi-agent front-line chemotherapy.
- Large-Cell, Anaplastic Lymphoma
- NK-cell Lymphoma
- T-cell Lymphoma
- Phase: I
- Enrollment: 39
- Start: February 2011
- Estimated Completion: June 2017
- Last verified: March 2015
Last Editorial review: July 15, 2016
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.
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