A Multicenter, Open-label Phase II Study on the Treatment of Newly Diagnosed Early-stage Hodgkin's Lymphoma With Zimberelimab (GLS-010) Combined With AVD Regimen (Doxorubicin, Vindesine, Dacarbazine) Under the Guidance of PET/CT
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Complete response rate (CRR) after 2 cycles
研究概览
简要总结
This is a multicenter, open-label single-arm phase II study to evaluate the efficacy and safety of Zimberelimab (GLS-010) combined with AVD for newly diagnosed early-stage Hodgkin's lymphoma under the guidance of PET/CT.
详细描述
Despite achieving good disease control and long-term survival rates for over 80% of classical Hodgkin lymphoma (cHL) patients who receive first-line therapy, approximately 10% of early-stage and 30% of advanced cHL patients experience disease relapse or refractoriness after initial treatment, and only half of the patients can be cured through high-dose therapy (HDT) and autologous stem cell transplantation (ASCT). Meanwhile, the current standard first-line treatment still centers around conventional chemotherapy with cytotoxic agents. As such, the clinical challenge of cHL first-line treatment lies in striking a balance between efficacy and toxicity, and developing low-toxicity, high-efficiency treatment strategies to achieve the optimal treatment goal of maximizing efficacy while minimizing short- and long-term toxicities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with primary classical Hodgkin lymphoma (HL) based on histopathology.
- •Stage I-II .
- •At least one measurable target lesion（Lugano 2014）.
- •Age 18 years or older (including 18 years) to 45 years (recent fertility requirements and concern about chemotherapy side effects), or age >60 years (older patients who are frail and unwilling to undergo chemotherapy), male or female.
- •ECOG PS 0-3,
- •Expected survival ≥ 3 months.
排除标准
- •Hodgkin's lymphoma with nodular lymphocyte predominant type.
- •Patients who are scheduled to undergo subsequent autologous stem cell transplantation.
- •Contraindications to radiotherapy.
- •With central nervous system (meningeal or parenchymal) involvement.
- •Contraindications to immune checkpoint inhibitors.
研究组 & 干预措施
Zimberelimab combined with or without AVD sequential radiotherapy
- Combination therapy： Subjects received Zimberelimab 240mg Q3W 2 cycle.
According to the results of PET/CT evaluation:
CR: Additional 2 cycles of Zimberelimab (4 cycles of Zimberelimab monotherapy in total); PR: 2 cycles of Zimberelimab+ AVD therapy (only PR patients combined with AVD). Subjects who did not achieve a Partial Response (PR) or Complete Response (CR) in their initial or subsequent efficacy evaluations, and whose potential for benefit was deemed unlikely by the investigator, were discontinued from the study. 2. Radiotherapy treatment period (patients with CR/PR): Sequentially radiation therapy 20-30Gy.
干预措施: Zimberelimab 240mg (Drug)
结局指标
主要结局
Complete response rate (CRR) after 2 cycles
时间窗: Up to approximately 2 months
Percentage of the sum of the number of patients in complete remission (CR), complete remission without confirmation (CRu) to the total number of patients in the full analysis set
次要结局
- Overall survival (OS)(Up to approximately 2 years)
- Incidence and severity of adverse events(AEs)(Up to approximately 2 years)
- Objective response rate (ORR) after 4 cycles ( Lugano2014)(Up to approximately 2 years)
- Complete response rate (CRR) after 4 cycles ( Lugano2014)(Up to approximately 2 years)
- Total ORR and CRR after Zimberelimab treatment + radiotherapy(Up to approximately 2 years)
- Duration of response (DOR)(Up to approximately 2 years)
- Progression-free survival time (PFS)(Up to approximately 2 years)
研究者
Li Zhiming
Professor
Sun Yat-sen University