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

Children's Cancer Group, China1 个研究点分布在 1 个国家目标入组 96 人开始时间: 2024年9月25日最近更新: 2025年2月13日

适应症

干预措施

试验速览

阶段: 2 期
状态: 招募中
发起方
入组人数: 96
试验地点: 1
主要终点: Early complete metabolic response rate for the entire group

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 2 Years 至 35 Years（Child, Adult）
性别: All
接受健康志愿者: 否

入选标准

•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;

排除标准

•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

研究组 & 干预措施

High risk group

Experimental

Stage IIB Stage IIIB Stage IV

干预措施: Brentuximab Vedotin for Injection (Drug)

High risk group

Experimental

Stage IIB Stage IIIB Stage IV

干预措施: response-adapted radiation (Radiation)

Low risk group

Experimental

Stage IA , no bulky Stage IIA, no bulky

干预措施: Brentuximab Vedotin for Injection (Drug)

Low risk group

Experimental

Stage IA , no bulky Stage IIA, no bulky

干预措施: response-adapted radiation (Radiation)

Low risk group

Experimental

Stage IA , no bulky Stage IIA, no bulky

干预措施: Doxorubicin (Drug)

Low risk group

Experimental

Stage IA , no bulky Stage IIA, no bulky

干预措施: Etoposide (Drug)

Low risk group

Experimental

Stage IA , no bulky Stage IIA, no bulky

干预措施: Prednisone (Drug)

Low risk group

Experimental

Stage IA , no bulky Stage IIA, no bulky

干预措施: Cyclophosphamide (Drug)