Clinical Study on the Efficacy and Safety of Anti-PD-1 Monoclonal Antibody Combined Lenalidomide and Azacitidine in Relapsed/Refractory Peripheral T-cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Progression-free Survival(PFS)
研究概览
简要总结
Aim of this study will evaluate the Efficacy and Safety of Anti-PD-1 monoclonal antibody Combined Lenalidomide and Azacitidine in Relapsed/Refractory Peripheral T-cell Lymphoma Patients.
详细描述
Peripheral T-cell lymphomas (PTCLs) are malignancies of immunologically mature T-cells that arise in peripheral lymphoid tissues. Compared with B-cell lymphoma, the treatment methods of PTCL are more limited, the first-line therapy is usually CHOP-like therapy, but the efficacy is poor, 5-year overall survival rate (OS) is only 30%-40%. Anti-PD-1 monoclonal antibody, Lenalidomide and Azacitidine can all have tumor-killing effects, and the three have complementary theoretical basis in the mechanism of action. This study will evaluate the efficacy and safety of Anti-PD-1 monoclonal antibody Combined Lenalidomide and Azacitidine in Relapsed/Refractory Peripheral T-cell Lymphoma patients.
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
- •Pathological immunohistochemistry or flow cytometry confirmed that R/R PTCL with measurable (diameter greater than 1.5cm) lesions meets any of the following conditions: 1> After 4 courses of standard first-line therapy or 2 courses of more than two-line therapy, the lesions were reduced by <50%; 2> PTCL with disease progression after first-line or induction therapy; 3> After hematopoietic stem cell transplantation, new lesions appear or the size of previously affected lesions increased by more than 50%.
- •Age ≥ 18 years.
- •The main organ functions need to meet the following conditions:Hemogram needs to meet HB ≥70*1012/L，PLT≥50*109/L，NE≥1*109/L；LVEF≥50%;CR≤132umol/l or CCr≥60 ml/min;ALT and AST≤2 times normal range；Lung function≤Level 1;dyspnea(CTCAE v5.0),and blood oxygen saturation without oxygen absorption> 91%.
- •Subjects of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study until the follow-up one year period of the study.
- •Estimated survival time ≥3 months.
- •Voluntary signing of informed consent.
排除标准
- •Accepted major surgery within 4 weeks before treatment.
- •Prior malignancy (other than Relapsed/Refractory Peripheral T-cell Lymphoma), except for cured malignant tumors with no active lesions for 3 years;Adequate treatment of inactive lesions in non-melanoma skin cancer,malignant tonsilloma or carcinoma in situ;
- •Patients who have previously received failed allogeneic hematopoietic stem cell transplantation.
- •Have stroke or intracranial hemorrhage within 3 months.
- •Evidence of complications or medical conditions, including but not limited, that may interfere the conduct of the study or place the patient at serious risk:significant cardiovascular disease(class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification、myocardial infarction within 6 months of screening、uncontrolled or symptomatic arrhythmias) and/or significant lung disease.
- •HIV infection and/or active hepatitis B or active hepatitis C.
- •Uncontrolled systemic infection.
- •Pregnant or breasting-feeding women.
- •According to the researchers' judgment, any life-threatening disease, medical condition or organ system dysfunction which can endanger the patient's safety and Interfer with the absorption or metabolism of anti-PD-1 monoclonal antibody plus Lenalidomide and Azacitidine,may put the results of a study at unnecessary risk.
研究组 & 干预措施
Anti-PD-1 monoclonal antibody+Lenalidomide+Azacitidine
Anti-PD-1 monoclonal antibody plus Lenalidomide, Azacitidine
干预措施: Anti-PD-1 monoclonal antibody (Drug)
Anti-PD-1 monoclonal antibody+Lenalidomide+Azacitidine
Anti-PD-1 monoclonal antibody plus Lenalidomide, Azacitidine
干预措施: Lenalidomide (Drug)
Anti-PD-1 monoclonal antibody+Lenalidomide+Azacitidine
Anti-PD-1 monoclonal antibody plus Lenalidomide, Azacitidine
干预措施: Azacitidine (Drug)
结局指标
主要结局
Progression-free Survival(PFS)
时间窗: up to 12 months
To measure the duration of response to Anti-PD-1 antibody plus Lenalidomide and Azacitidine over a follow-up period of 12 months
Overall Response Rate (ORR)
时间窗: up to 12 months
To measure the duration of response to Anti-PD-1 antibody plus Lenalidomide and Azacitidine over a follow-up period of 12 months
Overall Response Rate (ORR) at 6 cycles
时间窗: From date of first dose until completion of 6 treatment cycles, assessed up to approximately 20 weeks.
The percentage of participants achieving a best overall response of confirmed Complete Response (CR) or Partial Response (PR) after treatment by Anti-PD-1 antibody plus Lenalidomide and Azacitidine.
次要结局
- Adverse events profile(Measured from start of treatment until 28 days after last dose)
- Overall Survival(up to 12 months)
- Complete Response Rate(up to 12 months)
- Duration of Response(up to 12 months)
- Complete Response Rate at 6 cycles(From date of first dose until completion of 6 treatment cycles, assessed up to approximately 20 weeks.)
- 3-year progression-free survival (PFS) rate(up to 3 years)
- 3-year Overall Survival(OS) Rate(up to 3 years)