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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Early complete metabolic response rate for the entire group — 5 years
  Early complete metabolic response rate after 2 cycle of Bv-AEPC based on PET/CT result for the entire group
• Late complete metabolic response rate in intermediate/high risk group — 5 years
  Late complete metabolic response rate based on PET/CT results for patients who did not achieve early complete metabolic response after 2 or 3 cycles of Bv-Dac-AEPC
• Complete metabolic response rate in intermediate/high risk group after modified Check Mate 744 regimens — 5 years
  Complete metabolic response rate based on PET/CT results for patients who receive a modified Check Mate 744 regimen
• Overall survival rate for the entire group and each risk group — 5 years
  the overall survival rate for all the patients enrolled

Trial sites (1)

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