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Brentuximab Vedotin for Newly Diagnosed cHL in Chinese CAYA Based on PET/CT Assessment
Sponsor: Children's Cancer Group, China
Summary
Generally, pediatric patients tolerate acute toxicities but are vulnerable to late effects. Thus, increasing chemotherapy intensity to achieve more rapid complete early response to limit radiation therapy is worth testing. In this CCCG-HL-2024 study, Brentuximab vedotin (Bv) was used to replace VCR and bleomycin in the ABVE-PC regimen in the previous CCCG-HD-2018 study, respectively, to form a Bv-AEPC regimen for the treatment of newly diagnosed classic Hodgkin lymphoma (cHL) in children, adolescents and young adults. On the premise of maintaining a 4-year event free survival (EFS)\>90% in the low-, intermediate-and high-risk groups, increase the early assessment complete response rate (the overall early complete response rate increased by 20%, that is, from 54.0% to 74.0%) to further reduce the proportion of children receiving radiotherapy to benefit them.
Official title: A Phase II/III Study of Brentuximab Vedotin for Newly Diagnosed Classical Hodgkin Lymphoma in Chinese CAYA Based on PET/CT Assessment
Key Details
Gender
All
Age Range
2 Years - 35 Years
Study Type
INTERVENTIONAL
Enrollment
96
Start Date
2024-09-25
Completion Date
2039-11-15
Last Updated
2026-03-19
Healthy Volunteers
No
Conditions
Interventions
Brentuximab Vedotin for Injection
1.8mg/kg/dose (MAX 180 mg)
response-adapted radiation
For patients who did not achieve complete metabolic response at early response assessment based on PET/CT result.
Doxorubicin
25mg/m2/dose,
Etoposide
125 mg/m2/dose
Prednisone
20 mg/m2, BID, orally
Cyclophosphamide
600 mg/m2/dose
Dacarbazine
250 mg/m2/dose; For patients in intermediate/high risk group who did not achieve complete metabolic response at early assessment based on PET/CT results.
Tislelizumab Injection
3mg/kg/dose; For patients in intermediate/high risk group who did not achieve complete metabolic response at late assessment based on PET/CT results.
Bedamustine
180mg/m2/dose; For patients in intermediate/high risk group who did not achieve complete metabolic response at late assessment based on PET/CT results.
Locations (1)
Shanghai Children's Medical Center
Shanghai, China