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

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.

Conditions

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

Interventions

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.

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.

Sponsors & Collaborators

• Shanghai Children's Medical Center

  collaborator OTHER

• Najing Children's Hospital

  collaborator UNKNOWN

• West China Second University Hospital

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• Tianjin Medical University Cancer Institute and Hospital

  collaborator OTHER

• Tongji Hospital

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Second Affiliated Hospital of Anhui Medical University

  collaborator UNKNOWN

• Children's Hospital of Hebei Province

  collaborator OTHER

• Children's Hospital of Henan Province

  collaborator UNKNOWN

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  collaborator OTHER

• Children's Cancer Group, China

  lead NETWORK

Principal Investigators

• YI JIN GAO, MD · Shanghai Children's Medical Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

2 Years

Max Age

35 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-25

Primary Completion

2029-11-15

Completion

2039-11-15

Countries

• China

Study Locations