NCT06671717尚未招募不适用
Pralatrexate Combined With Chidamide Bridging Allogeneic Hematopoietic Stem Cell Transplantation for Refractory/Relapsed Peripheral T-cell Lymphoma
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS) at 1 year after transplantation
研究概览
简要总结
This is a multicenter, prospective study of Pralatrexate combined with Chidamide bridging Allogeneic Hematopoietic Stem Cell Transplantation for Refractory/Relapsed Peripheral T-cell 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients fully understand the study, voluntarily participate in and sign on the informed consent;
- •Diagnosed by histopathology Peripheral T-cell lymphoma;
- •ECOG PS score 0 or 1;
- •Relapsed or Refractory Peripheral T Cell Lymphoma；
- •According to the 2014 version of the Lugano criteria for lymphoma, there must be at least one CT/MRI measurable lesion (measurable lymph node diameter>1.5cm; measurable extranodal lesion diameter>1.0cm)；
- •Provided a written pathological/histological diagnosis report during the screening period and agreed to provide tumor tissue sections or tumor/lymph node tissue specimens for testing at the central laboratory;
- •Expected survival at least 12 weeks；
- •Agreed to receive treatment with Pralatrexate
排除标准
- •NK/T-cell lymphoma;
- •Achieving CR or PR after induction chemotherapies without relapse;
- •Dysfunction of vital organs;
- •Serious history of autoimmune diseases and immunodeficiency, including: positive for human immunodeficiency virus (HIV) antibodies; Or other acquired or congenital immunodeficiency diseases; Or have a history of organ transplantation;
- •Unwilling to accept allogeneic hematopoietic stem cell transplantation;
- •Undergoing other clinical studies within a month;
- •Without donor for transplantation;
- •Allergies to similar drugs and excipients of the research drug
研究组 & 干预措施
Pralatrexate combined with Chidamide bridging allo-HSCT for Relapse/Refractory PTCL patients
Experimental
Pralatrexate combined with Chidamide bridging allo-HSCT for Relapse/Refractory PTCL patients
干预措施: Pralatrexate combined with Chidamide bridging Allogeneic Hematopoietic Stem Cell Transplantation (Other)
结局指标
主要结局
Progression-free survival (PFS) at 1 year after transplantation
时间窗: Participants will be followed for an expected average of 1 years after transplantation
The time from the end of transplantation to progression of disease or death at 1year
次要结局
未报告次要终点
研究者
Xiao-Jun Huang
Director
Peking University People's Hospital
研究点 (1)
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