Interim PET/CT-adapted Use of PD-1 Inhibitor Combined With De-escalated Chemotherapy-AVD in Classic Hodgkin Lymphoma
2026年7月18日 更新者:Xiao-Jun Huang、Peking University People's Hospital
A Prospective Single-institution Phase II Study of Interim PET/CT-adapted PD-1 Inhibitor Addition to First-line Chemotherapy for Unfavorable Stage II and Stage III/IV Classical Hodgkin Lymphoma to Omit High-dose Chemotherapy and Radiotherapy
This study enrolls newly diagnosed unfavorable stage II /stage III-IV classical Hodgkin lymphoma patients.
All participants receive 2 cycles ABVD induction chemotherapy, then stratified by interim PET-CT Deauville score for differentiated treatment: standard ABVD for DS1-3, AVD plus Sintilimab for DS4, salvage chemotherapy plus autologous stem cell transplant for DS5.
The primary goal is to assess 2-year progression-free survival and compare long-term survival and toxicities across subgroups, to verify whether Sintilimab addition can avoid high-dose chemo-radiotherapy for DS4 patients.
研究概览
研究类型
介入性
注册 (实际的)
130
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
-
Beijing、中国
- Peking University People's Hospital
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-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Age ≥ 18 years old;
- Histologically confirmed newly diagnosed classical Hodgkin lymphoma (cHL);
- Eligible to receive standard frontline ABVD induction chemotherapy for 2 cycles;
- Able to complete interim PET-CT (iPET2) scan after 2 cycles ABVD for Deauville score stratification;
- Adequate bone marrow, hepatic and renal function to tolerate chemotherapy and immunotherapy;
- Life expectancy ≥ 6 months at enrollment;
- Willing to comply with scheduled treatment, imaging follow-up and laboratory tests;
Exclusion Criteria:
- Prior systemic anti-lymphoma therapy, including chemotherapy, radiation, anti-PD-1/PD-L1 immunotherapy or stem cell transplantation;
- Severe irreversible organ dysfunction (cardiac, pulmonary, hepatic, renal) that cannot tolerate cytotoxic chemotherapy;
- Known hypersensitivity to doxorubicin, bleomycin, vinblastine, dacarbazine or sintilimab;
- Active severe infection (e.g., uncontrolled sepsis, active tuberculosis, HIV infection);
- Pregnant or breastfeeding female patients;
- Inability to complete serial PET-CT imaging due to contraindications such as severe contrast allergy
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:iPET2 Stratified ABVD-Based Treatment Arm
All patients receive 2 cycles of frontline ABVD induction chemotherapy first, then treatment is stratified by iPET2 Deauville score: DS 1-3: Complete standard full-course ABVD chemotherapy; DS 4: AVD combined with Sintilimab maintenance to avoid high-dose chemo-radiotherapy; DS 5: Salvage intensive chemotherapy followed by autologous stem cell transplantation |
Combination chemotherapy containing Doxorubicin, Bleomycin, Vinblastine and Dacarbazine, 2 cycles as uniform frontline induction treatment for all eligible patients.
Anti-PD-1 monoclonal antibody Sintilimab, combined with AVD chemotherapy and given as maintenance therapy for patients with iPET2 Deauville Score 4 to avoid high-dose chemo-radiotherapy.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
2-year Progression-Free Survival (PFS)
大体时间:2 years after completion of all assigned treatment
|
Time from study enrollment to first disease progression or death from any cause, stratified by iPET2 Deauville score subgroups.
Disease progression is confirmed by radiological imaging evaluation.
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2 years after completion of all assigned treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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5-year Progression-Free Survival (PFS)
大体时间:5 years after completion of all assigned treatment
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Long-term progression-free survival up to 5 years after treatment completion, compared across iPET2 stratified subgroups.
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5 years after completion of all assigned treatment
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Incidence of All-Grade and Grade 3-5 Adverse Events
大体时间:Throughout treatment period and 5-year long-term follow-up
|
Rate of hematological, non-hematological and Sintilimab-related immune adverse events graded per CTCAE v5.0 during treatment and follow-up.
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Throughout treatment period and 5-year long-term follow-up
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年2月1日
初级完成 (实际的)
2026年2月28日
研究完成 (实际的)
2026年2月28日
研究注册日期
首次提交
2026年7月18日
首先提交符合 QC 标准的
2026年7月18日
首次发布 (实际的)
2026年7月22日
研究记录更新
最后更新发布 (实际的)
2026年7月22日
上次提交的符合 QC 标准的更新
2026年7月18日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
未定
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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