NCT07168317招募中2 期
Efficacy and Safety of Tislelizumab in Combination With Cyclophosphamide, Mitoxantrone Liposomes, Chidamide, and Prednisone in the Treatment of New Diagnosed AITL: a Multicenter, Single-arm, Prospective Clinical Study
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Outcome Measure
研究概览
简要总结
Angioimmunoblastic T-cell lymphoma (AITL) is a rare and aggressive lymphoma. At present, the treatment of new diagnosed AITL has limited efficacy and a high recurrence rate. The study seeks to explore the possibility of improving the efficacy of immunotherapy and chemotherapy and epigenetically regulated drugs.
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 diagnosis of AITL according to WHO classification in 2016, and pathological diagnosis of AITL according to WHO classification in 2016, and at least one evaluable or measurable lesion meeting Lugano2014 criteria: lymph node lesion, detectable lymph node length>1.5cm; non-lymph node lesion, detectable extra-nodal lesion length>1.0cm;
- •Never received systemic or local treatment including chemotherapy before;
- •Age ≥18 years old, male or female, ECOGPS≤3 points;
- •Life expectancy exceeds 3 months;
- •Follow-up conditions. Patients understand the characteristics of the disease and voluntarily join the study protocol for treatment and follow-up.
排除标准
- •Subjects who meet any of the following criteria are not eligible for inclusion in this study:
- •Patients with abnormal liver and kidney function, specifically serum direct bilirubin, serum indirect bilirubin and/or alanine aminotransferase, aspartate aminotransferase and serum creatinine>2 times normal values, unless abnormal liver and kidney function is considered to be related to lymphoma;
- •Bone marrow failure, specifically defined as absolute neutrophil count (ANC)<1.5*10^9/L or platelets <75*10^9/L or Hb<90g/L, unless changes in hemogram are considered to be associated with lymphoma infiltration of the bone marrow;
- •Patients who have previously received local or systemic anti-tumor treatment;
- •Chronic heart failure with cardiac function class III or IV; or left ventricular ejection fraction <50%; or patients with the following cardiac diseases within 6 months: acute coronary syndrome; acute heart failure (Class III or IV of cardiac function class); patients with a history of clinically significant QT prolongation (>450 ms for men,>470 ms for women), ventricular tachycardia (VT), atrial fibrillation (AF), heart block, symptomatic coronary heart disease requiring medical treatment;
- •AIDS, syphilis, active B (HBV DNA>1*10^4 copies/ml) and hepatitis C;
- •Patients with other malignancies that are not effectively controlled; or with other hematological disorders (e.g. hemophilia, myelofibrosis, etc.), the investigator considers that the patient is not suitable for enrollment;
- •History of autoimmune disease, receiving immunosuppressive therapy before enrollment, immunosuppressive dose>10 mg/day or oral prednisone for more than 2 weeks;
- •Clinically uncontrolled active infection (including bacterial, fungal or viral infections), and drug therapy is ineffective;
- •Patients with uncontrolled hemophagocytic syndrome;
- •Patients who have received secondary surgery or above within 3 weeks before treatment;
- •Patients who have participated in clinical trials of other drugs within 30 days before enrollment or are participating in clinical trials of other new drugs;
- •Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures;
- •Known allergies to investigational drug components;
- •The investigator considers that the enrollment is not suitable.
研究组 & 干预措施
Patients with new diagnosed angioblastic T cell lymphoma
Experimental
Patients with new diagnosed angioblastic T cell lymphoma
干预措施: tislelizumab in combination with cyclophosphamide, mitoxantrone liposomes, chidamide, and prednisone (Drug)
结局指标
主要结局
Outcome Measure
时间窗: Time forecasting: 24 months
To evaluate the Objective Response Rate (Complete response+Partial response) of tirelizumab in combination with cyclophosphamide, mitoxantrone liposomes, sidaraniline, and prednisone in subjects with relapsed/refractory angioimmunoblastic T-cell lymphoma
次要结局
- 24-month Overall Survival Rate in relapsed/refractory AITL(From first dose until death from any cause (assessed at 24 months))
- 24-month Progression-free Survival Rate in relapsed/refractory AITL(From first dose until first documented progression or death (assessed at 24 months))
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(Time forecasting: 24 months)
研究者
研究点 (1)
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