Xiangyang No.1 People's Hospital, Hubei University of Medicine
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- ORR
研究概览
简要总结
This study was a single-arm trial of autologous NK cell adjuvant therapy for relapsed/refractory non-Hodgkin's B-cell lymphoma. The locations isXiangyang No.1 People's Hospital, Hubei University of Medicine. The population was relapsed/refractory non-Hodgkin's B-cell lymphoma. The sample size was 33. The intervention was R-GemOx regimen combined with autologous NK cells. The dose of autologous NK cells was body surface area x (2-4) x 109 cells. The course of treatment was once every 14 days. The primary outcome measure was ORR. The duration of assessment was for each treatment cycle, 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 3 years, and 5 years of treatment.
详细描述
This study was a single-arm trial of autologous NK cell adjuvant therapy for relapsed/refractory non-Hodgkin's B-cell lymphoma. The locations isXiangyang No.1 People's Hospital, Hubei University of Medicine. The population was relapsed/refractory non-Hodgkin's B-cell lymphoma. The sample size was 33. The intervention was R-GemOx regimen combined with autologous NK cells. The dose of autologous NK cells was body surface area x (2-4) x 109 cells. The course of treatment was once every 14 days. The primary outcome measure was ORR. The duration of assessment was for each treatment cycle, 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 3 years, and 5 years of treatment.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with age 15 years to 80 years, with life expectancy greater than 6 months.
- •Pathologically confirmed non-Hodgkin B-cell lymphoma, confirmed by pathological examination at a grade A class 3 hospital or above, with pathology reported less than 3 years ago.
- •First diagnosed relapsed/refractory non-Hodgkin's B-cell lymphoma.
- •ECOG scores were 0 to 2
- •Presence of at least one CT measurable lesion locus with a maximum transverse diameter of ≥1.5 cm before inclusion in the study.
- •For women of childbearing potential, a negative pregnancy test must be confirmed before inclusion in the study and no intention to have children within 2 years.
- •For men of childbearing potential, inform and require the use of an effective barrier contraceptive method.
- •Volunteer to participate in the trial and sign the informed consent form.
排除标准
- •Presence of bone marrow or/and central nervous system lymphoma.
- •Patients with less than 5% peripheral blood NK cell percentage and pre-culture failure.
- •Combined with other malignancies.
- •Fever of non-disease-related origin within the last 5 days.
- •Presence of uncontrollable bacterial, fungal, viral or other infections.
- •Patients with HIV, TP positive
- •Patients with severe cardiopulmonary, hepatic and renal, and cerebral dysfunction are present.
- •Presence of other serious diseases that conflict with this protocol, such as autoimmune diseases, immunodeficiencies, severe thrombocytopenia, platelet dysfunction syndrome, etc.
- •Received any form of organ transplantation, including allogeneic stem cell transplantation.
- •Presence of a serious psychiatric disorder.
- •Inability to communicate normally and incapacitation make it difficult to assess the safety and effectiveness of treatment.
- •Pregnant or lactating women.
- •The researchers deemed unsuitable for participation in this study. -
结局指标
主要结局
ORR
时间窗: up to 5 years of treatment
Refer to the 2014 version of Lugano standard
次要结局
- PFS(up to 5 years of treatment)
- SD(up to 5 years of treatment)
- PD(up to 5 years of treatment)
- ECOG(up to 5 years of treatment)
- CR(up to 5 years of treatment)
- CBR(up to 5 years of treatment)
- OS(up to 5 years of treatment)
- PR(up to 5 years of treatment)
- DOR(up to 5 years of treatment)
- EORTC QLQ-C30(up to 5 years of treatment)
研究者
Bin Pei
Director
Xiangyang No.1 People's Hospital