A Phase II Study to Determine the Optimal Dose of Brentuximab Vedotin for Mycosis Fungoides and Lymphomatoid Papulosis

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Full Title

Optimizing Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome, and Lymphomatoid Papulosis

Purpose

Mycosis fungoides (MF) is a disease in which lymphocytes (a type of white blood cell) become cancerous and affect the skin, causing “cutaneous T-cell lymphoma.” Lymphomatoid papulosis (LyP) is a rare and similar disorder that causes lymphoma-like skin lesions.

Brentuximab vedotin is a medication used to treat MF. It has two parts: one (an antibody) that attaches to a protein on the surface of MF and LyP cells called CD30, and another (an anticancer drug called monomethyl auristatin E) that kills the cancer. The dose of brentuximab vedotin that is approved for MF, however, can cause weakness, numbness, and pain in the hands and feet and other areas of the body over time. This study will determine if a lower dose of brentuximab vedotin can avoid these side effects while still effectively treating MF and LyP.

Brentuximab vedotin is given intravenously (by vein).

Who Can Join

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

  • Patients must have MF (with or without CD30) or LyP (CD30-positive).
  • At least 2 weeks must pass between the completion of previous treatment and entry into the study.
  • 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. Alison Moskowitz at 212-639-4839.

Protocol

18-147

Phase

Phase II (phase 2)

Investigator

Co-Investigators

Patricia Myskowski

ClinicalTrials.gov ID

NCT03587844