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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age2-35
SponsorChildren's Cancer Group, China

About this trial

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 criteria

Qualifiers

Ages >=2~<35 years at the time of enrollment;

Patients with newly diagnosed, pathologically confirmed classical Hodgkin lymphoma (HL) by at least 2 tertiary referral centers for pathology;

Adequate organ function;

Patients and/or their parents or legal guardians sign a written informed consent;

Disqualifiers

Patients with nodular lymphocyte-predominant HL;

Patients with an immunodeficiency that existed prior to diagnosis; such as primary immunodeficiency syndromes, organ transplant recipients and children on current systemic immunosuppressive agents are not eligible;Patients known to be positive for HIV are not eligible.

Patients who are pregnant; Lactating females who plan to breastfeed.

Patients who received systemic corticosteroids within 28 days of enrollment on this protocol

Trial design

Treatments tested in this trial

  • Brentuximab Vedotin for Injection
  • response-adapted radiation
  • Doxorubicin
  • Etoposide
  • Prednisone
  • Cyclophosphamide
  • Dacarbazine
  • Tislelizumab Injection
  • Bedamustine

Treatment groups

96 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Children's Cancer Group, China

Lead sponsor

Shanghai Children's Medical Center

Collaborator

Najing Children's Hospital

Collaborator

West China Second University Hospital

Collaborator

Qilu Hospital of Shandong University

Collaborator

Tianjin Medical University Cancer Institute and Hospital

Collaborator

Tongji Hospital

Collaborator

Xiangya Hospital of Central South University

Collaborator

The First Affiliated Hospital of Zhengzhou University

Collaborator

The Second Hospital of Anhui Medical University

Collaborator

Children's Hospital of Hebei Province

Collaborator

Children's Hospital of Henan Province

Collaborator

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

Collaborator