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RECRUITING
NCT06563245
PHASE2/PHASE3

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

Sponsor: Children's Cancer Group, China

View on ClinicalTrials.gov

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

Interventions

DRUG

Brentuximab Vedotin for Injection

1.8mg/kg/dose (MAX 180 mg)

RADIATION

response-adapted radiation

For patients who did not achieve complete metabolic response at early response assessment based on PET/CT result.

DRUG

Doxorubicin

25mg/m2/dose,

DRUG

Etoposide

125 mg/m2/dose

DRUG

Prednisone

20 mg/m2, BID, orally

DRUG

Cyclophosphamide

600 mg/m2/dose

DRUG

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.

DRUG

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.

DRUG

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