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.
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;
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
Single group
Brentuximab Vedotin for Injection
Drug1.8mg/kg/dose (MAX 180 mg)
response-adapted radiation
RadiationFor patients who did not achieve complete metabolic response at early response assessment based on PET/CT result.
Doxorubicin
Drug25mg/m2/dose,
Etoposide
Drug125 mg/m2/dose
Prednisone
Drug20 mg/m2, BID, orally
Cyclophosphamide
Drug600 mg/m2/dose
Dacarbazine
Drug250 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
Drug3mg/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
Drug180mg/m2/dose; For patients in intermediate/high risk group who did not achieve complete metabolic response at late assessment based on PET/CT results.
Early complete metabolic response rate for the entire group
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
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
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
the overall survival rate for all the patients enrolled
Click on the lead sponsor to view all of their trials.
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
