Excellent Outcome for Pediatric Patients With High-Risk Hodgkin Lymphoma Treated With Brentuximab Vedotin and Risk-Adapted Residual Node Radiation.
Monika L Metzger, Michael P Link, Amy L Billett...
https://pubmed.ncbi.nlm.nih.gov/33826362/Actively Recruiting
Led by Children's Cancer Group, China · Updated on 2026-03-19
96
Participants Needed
1
Research Sites
521 weeks
Total Duration
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 PETCT scan results to improve outcomes and minimize toxicity. Participants will undergo early and late assessments using PETCT 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.
CONDITIONS
Brentuximab Vedotin for Newly Diagnosed cHL in Chinese CAYA Based on PET/CT Assessment
Y
YI JIN GAO, MD
J
JIE ZHAO
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Children's Cancer Group, China
Lead Sponsor
Shanghai Children's Medical Center
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Varies by participant risk group and response; includes multiple treatment cycles and response assessments up to several months
Participants receive the Bv-AEPC chemotherapy regimen for newly diagnosed classical Hodgkin lymphoma. Intermediate and high-risk participants who do not achieve complete metabolic remission at early PET/CT assessment receive an intensive Bv-Dac-APC regimen for 2 or 3 courses. Those who still do not achieve remission after this receive a modified Check Mate 744 regimen including PD-1 monoclonal antibody, Brentuximab vedotin, and possibly bedamustine, autologous stem cell transplantation, or radiotherapy.
Multiple visits for chemotherapy and PET/CT assessments as per treatment schedule
Duration - Up to 5 years
Participants are monitored for treatment response, event-free survival, and overall survival over 5 years after treatment completion.
Periodic follow-up visits over 5 years
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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https://pubmed.ncbi.nlm.nih.gov/23927803/Children's Cancer Group, China
Lead Sponsor
Shanghai Children's Medical Center
Collaborating Sponsor