A Phase II/III Study of Brentuximab Vedotin for Newly Diagnosed Classical Hodgkin Lymphoma in Chinese Children, Adolescents, and Young Adults Based on PET/CT Assessment

What this Trial Is About

Researchers are evaluating a new treatment approach for children, adolescents, and young adults newly diagnosed with classical Hodgkin lymphoma (cHL). This study aims to improve early complete response rates while maintaining high 4-year event-free survival across all risk groups. The trial explores replacing certain drugs in the previous standard chemotherapy regimen with Brentuximab vedotin to reduce the need for radiation therapy and lower long-term side effects. The trial uses a modified chemotherapy regimen called Bv-AEPC, where Brentuximab vedotin replaces vincristine and bleomycin. Patients are grouped by risk level (low, intermediate, high). Those in the intermediate and high-risk groups who do not achieve complete metabolic remission early will receive more intensive treatment with additional drugs and potentially a PD-1 antibody, along with stem cell transplant or radiation if needed. Treatment plans adapt based on PET/CT scan results to improve outcomes and minimize toxicity. Participants will undergo early and late assessments using PET/CT scans to measure metabolic response. Researchers will monitor event-free survival, overall survival, and response rates over five years. The study involves regular follow-ups to evaluate treatment effects, with the goal of reducing radiation exposure and improving long-term health. Children and young adults will receive comprehensive care and monitoring throughout the trial period, which starts with enrollment at age 2 through 35 years and continues with several years of outcome assessment.

Brentuximab Vedotin for Newly Diagnosed cHL in Chinese CAYA Based on PET/CT Assessment