A Phase II Study of Brentuximab Vedotin and CHP Chemotherapy in People with Previously Untreated Peripheral T-Cell Lymphoma

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Full Title

A Dual-cohort, Open-label, Phase 2 Study of Brentuximab Vedotin and CHP (A+CHP) in the Frontline Treatment of Subjects with Peripheral T-cell Lymphoma (PTCL) with Less than 10% CD30 Expression

Purpose

The purpose of this study is to assess the safety and effectiveness of combining the drug brentuximab vedotin with a standard chemotherapy regimen (cyclophosphamide, doxorubicin, and prednisone [CHP]) to treat people newly diagnosed with peripheral T-cell lymphoma (PTCL) that has low levels of a protein called CD30. Brentuximab vedotin is designed to target and attack cancer cells that express CD30 while leaving healthy cells undamaged.

Other studies have shown that brentuximab vedotin is an effective treatment for people who have PTCL with high levels of CD30. Researchers hope that adding brentuximab vedotin to CHP will be a more effective treatment than CHP alone in people whose cancer has low levels of CD30. The treatment is given intravenously (by vein) except for prednisone, which is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have PTCL (excluding systemic anaplastic large cell lymphoma) that has not yet been treated and has low CD30.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Steven Horwitz at 646-608-3725.

Protocol

21-170

Phase

II

Investigator

Co-Investigators