NCT06190067招募中2 期
Azacitidine Plus PD-1 Therapy for Relapsed/Refractory Hodgkin Lymphoma
Navy General Hospital, Beijing1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年10月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
The goal of this phase 2 trial is to test the safety and efficacy of azacitidine when given together with PD-1 therapy in treating patients with relapsed/refractory classic Hodgkin lymphoma.
详细描述
The investigators will evaluate response rate, progression free survival (PFS), overall survival (OS), and toxicity of azacytidine combined with PD-1 therapy in classic relapsed/refractory Hodgkin lymphoma.
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
- •Pathologically confirmed Hodgkin Lymphoma according World Health Organization (WHO) classification.
- •Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).
- •Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted.
- •Patient is willing and able to adhere to the study visit schedule and other protocol requirements.
- •Relapsed (after partial or complete response) or refractory AITL after at least one line of systemic therapy (there is no mandatory resting period after the previous treatment as long as the biochemistry and hematology labs meet the inclusion criteria as below).
- •Meet the following lab criteria: Absolute Neutrophil Count (ANC) ≥ 1,5 x 10^9/L (≥ 1 x 10^9/L if bone marrow (BM) involvement by lymphoma); Platelet ≥ 75 x 10^9/L (≥ 50 x 10^9/L if BM involvement by lymphoma); Hemoglobin ≥ 8 g/dL.
- •Anticipated life expectancy at least 3 months.
排除标准
- •Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.
- •Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.
- •Pregnant or lactating women.
研究组 & 干预措施
Azacitidine Plus PD-1 therapy
Experimental
Patients were treated by Azacitidine plus PD-1 therapy
干预措施: Azacitidine Plus PD-1 therapy (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: 1 year
ORR was defined as the proportion of patients who achieved CR or PR as their best response
次要结局
- Overall Survival (OS)(through study completion, an average of 2 year)
- Progression Free Survival (PFS)(18 months)
研究者
Liren Qian
Vice Director
Navy General Hospital, Beijing
研究点 (1)
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