NCT07058103招募中2 期
Efficacy and Safety of Tislelizumab in Combination With Cyclophosphamide, Mitoxantrone Liposomes, Chidamide, and Prednisone in the Treatment of R/R AITL: a Multicenter, Single-arm, Prospective Clinical Study
干预措施
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
- 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
研究概览
简要总结
Angioimmunoblastic T cell lymphoma (AITL) is a rare and aggressive lymphoma. Some patients relapsed after initial treatment or did not respond to standard treatment (refractory). Subsequent treatment options are limited and the efficacy is not ideal. This study attempts to explore the possibility of improving the efficacy of immunotherapy combined with chemotherapy and epigenetic regulatory 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;
- •Refractory or relapsed after at least one systemic therapy (including chemotherapy, stem cell transplantation)*;
- •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.
- •: Relapse: patients achieve complete response (CR) or partial response (PR), disease progression (PD) ≥6 months; refractory: treatment failure (no PR) or PD <6 months after the last chemotherapy.
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;
- •The subject's prior history of antineoplastic therapy meets one of the following conditions: (1) prior mitoxantrone or mitoxantrone liposome therapy;(2) prior PD-1 or PD-L1 inhibitor therapy;(3) Angioimmunoblastic T-cell lymphoma previously treated with histone deacetylase inhibitors;
- •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 relapsed/refractory angioblastic T cell lymphoma
Experimental
Patients with relapsed/refractory 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
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
时间窗: Time forecasting: 24 months
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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