Phase 2 Study of Mogamulizumab to Prevent Adult T-cell LeukemiaLymphoma in Adults With HTLV-1 Infection at High Risk

What this Trial Is About

Researchers are studying whether the drug mogamulizumab can help prevent adult T-cell leukemialymphoma ATL in people at high risk due to infection with the HTLV-1 virus and immune cell changes. This phase 2 trial focuses on people infected with HTLV-1 who have a higher chance of developing ATL, aiming to see if mogamulizumab reduces the viruss presence in their blood. Participants are assigned to one of two treatment groups receiving mogamulizumab Cohort 1 gets 0.3 mgkg every 12 weeks for 2 doses, and Cohort 2 receives 0.3 mgkg every 6 weeks for 4 doses. The study is non-randomized and unblinded, and treatments are given under medical supervision to evaluate dose effects on viral load reduction. During the study, participants undergo assessments including blood tests to measure the virus level, monitoring of organ function, and safety checks like electrocardiograms. Researchers will primarily measure how much the viral load decreases six months after starting treatment. The study lasts through the treatment period and follow-up, with careful observation to understand mogamulizumabs impact on preventing ATL development.

A Study of Mogamulizumab to Prevent Adult T-cell Leukemia/Lymphoma in People With HTLV-1