NCT06563245

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

A Phase II/III Study of Brentuximab Vedotin for Newly Diagnosed Classical Hodgkin Lymphoma in Chinese CAYA Based on PET/CT Assessment

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Children's Cancer Group, China · Network
• Sex: All
• Age: 2 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. Bv is currently the most widely used "new drug" in childhood cHL. For patients in the intermediate/high-risk group who did not achieve metabolic complete remission rate (CMR) at the early assessment based on PET/CT results, an intensive regimen of Bv-Dac-APC (Bv-APC plus dacarbazine) was applied for 2 or 3 courses to further improve event-free survival without increasing long-term reproductive toxicity. For patients in the intermediate/high-risk group who did not achieve CMR after the Bv-Dac-AEPC regimen, a modified Check Mate 744 regimen (PD-1 monoclonal antibody, Bv,+/-bedamostine, autologous stem cell transplantation/radiotherapy) was applied to improve the CMR of patients before irradiation, hoping to reduce the primary treatment failure rate to almost zero.

Conditions

• Classical Hodgkin Lymphoma
• Child
• Adolescent
• Young Adult
• Metabolic Response
• Survival
• Treatment
• Brentuximab Vedotin
• PET Scan

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-25
• Primary completion: 2029-11-15
• Completion: 2039-11-15
• First posted: 2024-08-20
• Last updated: 2026-03-19

Locations

1 site across 1 country: China