Testing Lower Doses of Brentuximab Vedotin for Treating Mycosis Fungoides, Sezary Syndrome, and Lymphomatoid Papulosis

What this Trial Is About

Researchers are evaluating the effects of brentuximab vedotin at lower doses than those approved by the FDA in patients with Mycosis Fungoides MF, Sezary Syndrome SS, and Lymphomatoid Papulosis LyP. This phase 2 trial aims to understand both the beneficial and adverse effects of the drug at these reduced doses. The study includes patients with confirmed diagnoses of these conditions and focuses on optimizing dosing to improve treatment outcomes. Participants receive brentuximab vedotin in three different groups based on their treatment history and condition. Patients with MFSS who have not received brentuximab vedotin are treated with doses of 0.9 mgkg or 1.2 mgkg. Those previously treated with the drug receive the dose determined to be promising in the first group, currently 1.2 mgkg. Patients with LyP receive 0.9 mgkg of the drug via intravenous infusion every three weeks. Treatment delays longer than eight weeks due to toxicity can result in removal from the study. During the study, participants undergo regular monitoring for treatment response and safety. The primary outcome measure is the overall response after one year. Assessments include clinical evaluations, performance status checks, and safety monitoring for side effects such as neuropathy or organ impairment. The study also requires stable use of steroids if applicable and adherence to birth control for females of childbearing potential. Participation may last several months with ongoing evaluations throughout the treatment period and follow-up as needed.

Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients