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

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).

Protocol
18-147
Phase
Phase II (phase 2)
Investigator
Co-Investigators
ClinicalTrials.gov ID
NCT03587844