Efficacy and Safety of Modified BV-AVD-R Regimen in Chinese Children With Previously Untreated Intermediate- and High-risk Classical Hodgkin's Lymphoma: an Open Label, Non-randomized, Single-arm, Phase 2 Study From Single Center

Beijing Children's Hospital1 个研究点分布在 1 个国家目标入组 44 人开始时间: 2022年10月1日最近更新: 2024年1月12日

适应症

干预措施

试验速览

阶段: 2 期
状态: Enrolling By Invitation
发起方
入组人数: 44
试验地点: 1
主要终点: Overall Response Rate(ORR)

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

The goal of this clinical trial is to use modified Brentuximab Vedotin+doxorubicin+vinblastine+dacarbazine+Rituximab(BV-AVD-R) regimen in Chinese Classical Hodgkin's Lymphoma(HL) children. The main questions it aims to answer are:

[Overall Response Rate(ORR) :Complete Response(CR)+Partial Response(PR)]
[progression-free survival (PFS), event-free survival (EFS) and overall survival (OS) at 6 months and 1 year.] Participants will be given modified BV-AVD-R regimen according to rapid early responders (RER) or slow early responders (SER) after 2 cycles.

详细描述

This study is a prospective study with period from October 2022 to December 2024, and planned to enroll 44 children with newly diagnosed intermediate- and high-risk classical HL. All patients will undergo Positron Emission Tomography(PET)/Computed Tomography(CT) at the time of initial diagnosis and after 2 cycles of modified BV+R+AVD regimen to determine early response. Rapid early responders (RER) deﬁned as CR after 2 cycles of therapy. Slow early responders (SER) defined as no CR (partial response (PR) or stable disease) after 2 cycles of therapy. Intermediate-risk patients were stage IA bulk/E, IB, IIA bulk/E, IIB, and IIIA. High-risk patients were stage IIB bulk/E, IIIA bulk/E, IIIB, and IVA/B.

The primary endpoints include ORR (CR+PR) and adverse events. The secondary endpoints include progression-free survival (PFS), event-free survival (EFS) and overall survival (OS) at 6 months and 1 year.

研究设计

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

入排标准

年龄范围: — 至 18 Years（Child, Adult）
性别: All
接受健康志愿者: 否

入选标准

•Age ≤ 18 years old, regardless of gender;
•According to the WHO classification criteria in 2016, pathologically confirmed classic Hodgkin's lymphoma is immunohistochemical CD30 positive;
•Newly diagnosed classic Hodgkin's lymphoma: all stages
•The main organs function normally and meet the following definitions:
•Blood routine examination: neutrophil count ≥ 1.5 x 109/L, platelet count ≥ 75 x 109/L, hemoglobin count ≥ 80 g/dL; Liver and kidney function: AST and ALT ≤ 2.0 upper limit of normal values; Bilirubin ≤ 2.0 mg/dL; Creatinine clearance rate ≥ 60 mL/min; 5) Functional status
•For patients aged 1-16, the Lansky score is ≥ 60 points.
•For patients over 16 years old, the Karnofsky score is ≥ 60 points. 6) Previous treatment
•Except for emergency mediastinal irradiation (<1000cGy) due to superior vena cava (SVC) syndrome, Hodgkin's lymphoma guidance treatment was not allowed before.
•Informed consent
•Patients or their legally authorized guardians must have a thorough understanding of their illness and the nature of the study (including foreseeable risks and possible adverse reactions), and must sign an informed consent form.

排除标准

•Karnofsky<60% or Lansky<60% for individuals under 16 years old.
•Children with Hodgkin's lymphoma who have received other chemical and radiation treatments.
•Initially rated as low-risk pediatric classic Hodgkin's lymphoma (IA, IIA, without large masses)

研究组 & 干预措施

Intermediate Risk

Experimental

Intermediate Risk Patients (Stage IA bulk/E, IB, IIA bulk/E, IIB, IIIA): 4 cycles of chemotherapy

干预措施: Brentuximab vedotin (Drug)

Intermediate Risk

Experimental

Intermediate Risk Patients (Stage IA bulk/E, IB, IIA bulk/E, IIB, IIIA): 4 cycles of chemotherapy

干预措施: Rituximab (Drug)

Intermediate Risk

Experimental

Intermediate Risk Patients (Stage IA bulk/E, IB, IIA bulk/E, IIB, IIIA): 4 cycles of chemotherapy

干预措施: Doxorubicin (Drug)

Intermediate Risk

Experimental

Intermediate Risk Patients (Stage IA bulk/E, IB, IIA bulk/E, IIB, IIIA): 4 cycles of chemotherapy

干预措施: Vincristine (Drug)

Intermediate Risk

Experimental

Intermediate Risk Patients (Stage IA bulk/E, IB, IIA bulk/E, IIB, IIIA): 4 cycles of chemotherapy

干预措施: Dacarbazine (Drug)