NCT06176027招募中1 期
Therapeutic Effect of Chemotherapy Azacytidine Plus CAOLD Regimen on Patients With Relapsed/Refractory Peripheral T-Cell Lymphomas
Navy General Hospital, Beijing1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年10月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
This is a multicenter prospective single arm phase II study. The purpose of this study is to evaluate the safety and efficiency of azacytidine combined with CAOLD Regimen in the treatment of relapsed/refractory peripheral t-cell lymphomas.
详细描述
The investigators will evaluate response rate, progression free survival (PFS), overall survival (OS), and toxicity of azacytidine combined with CAOLD Regimen in relapsed/refractory peripheral t-cell lymphomas.
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
- •Patients must satisfy all following criteria to be enrolled in the study:
- •Pathologically confirmed angioimmunoblastic T-cell 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
Azacytidine plus CAOLD regimen
Experimental
Patients were treated by Azacytidine plus CAOLD regimen
干预措施: Azacytidine plus CAOLD regimen (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
Associate Chief Physician, Associate Professor
Navy General Hospital, Beijing
研究点 (1)
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