NCT05495100Unknown2 期
A Single-arm, Multicenter, Prospective Clinical Study of Mitoxantrone Hydrochloride Liposome Injection Combined With Chidamide and Azacitidine in the Treatment of Relapsed and Refractory Peripheral T-cell Lymphoma
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2022年8月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
To evaluate the efficacy and safety of mitoxantrone hydrochloride liposome injection combined with chidamide and azacitidine in the treatment of relapsed and refractory 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients fully understand this study, voluntarily participate in and sign an informed consent form (ICF);
- •Age: 18~75 years old;
- •Expected survival time ≥ 3 months;
- •Histopathologically confirmed PTCL, one of the following subtypes:
- •(1) Peripheral T-cell lymphoma unspecified (PTCL-NOS) (2) Angioimmunoblastic T-cell lymphoma (AITL) (3) Anaplastic large T-cell lymphoma (ALCL), ALK+ (4) Anaplastic large T-cell lymphoma (ALCL), ALK- (5) Other subtypes of PTCL that the researchers believe can be enrolled;
- •Relapsed/refractory patients who have received at least first-line systemic therapy with anthracycline-containing regimens in the past. Relapse was defined as relapse after CR or progression after PR; refractory was defined as previous systemic chemotherapy treatment, 2 cycles of response evaluation as PD, or 4 cycles of response evaluation as SD;
- •There must be at least one evaluable or measurable lesion that meets the Lugano2014 criteria: lymph node lesions, measurable lymph nodes should be >1.5cm in length; non-lymph node lesions, measurable extranodal lesions should be >1.0cm in length;
- •ECOG score 0-2 points;
- •Bone marrow function: neutrophil count ≥1.5×109/L, platelet count ≥75×109/L, hemoglobin ≥80g/L (the neutrophil count in patients with bone marrow involvement can be relaxed to ≥1.0×109/L, Platelet count can be relaxed to ≥50×109/L, and hemoglobin can be relaxed to ≥75 g/L); Liver and kidney function: Serum creatinine ≤1.5 times the upper limit of normal; AST and ALT ≤2.5 times the upper limit of normal (for patients with liver involvement ≤5 times the upper limit of normal); total bilirubin ≤1.5 times the upper limit of normal (for liver involvement patients ≤ 3 times the upper limit of normal);
排除标准
- •The subject's previous history of anti-tumor therapy meets one of the following conditions:
- •Those who have received mitoxantrone or mitoxantrone liposome in the past;
- •Have received doxorubicin or other anthracycline therapy in the past, and the total cumulative dose of doxorubicin is more than 360 mg/m2 (1 mg doxorubicin equivalent to 2 mg epirubicin converted from other anthracyclines);
- •Patients who have received autologous hematopoietic stem cell transplantation within 100 days of the first medication, or have received allogeneic hematopoietic stem cell transplantation;
- •Received anti-tumor therapy (including chemotherapy, targeted therapy, hormone therapy, taking traditional Chinese medicine with anti-tumor activity, etc.) or participated in other clinical trials and received clinical trial drugs within 4 weeks before the first use of the study drug;
- •Hypersensitivity to any study drug or its components;
- •Uncontrollable systemic diseases (such as advanced infection, uncontrollable hypertension, diabetes, etc.);
- •Cardiac function and disease meet one of the following conditions:
- •Long QTc syndrome or QTc interval >480 ms;
- •Complete left bundle branch block, second or third degree atrioventricular block;
- •severe, uncontrolled arrhythmia requiring medical treatment;
- •New York College of Cardiology classification ≥ grade III;
- •Cardiac ejection fraction (LVEF) less than 50%;
- •History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia, or any other arrhythmia requiring treatment, clinically significant pericardial disease within 6 months prior to recruitment, or acute ischemic or active ECG evidence of conduction system abnormalities.
- •Active infection of hepatitis B and C (HBV surface antigen positive and hepatitis B virus DNA more than 1x103 copies/mL; hepatitis C virus RNA more than 1x103 copies/mL);
- •Human immunodeficiency virus (HIV) infection (HIV antibody positive);
- •Past or present with other malignant tumors (except for effectively controlled non-melanoma skin basal cell carcinoma, breast/cervical carcinoma in situ, and other malignant tumors that have been effectively controlled without treatment within the past five years);
- •Suffering from primary or secondary central nervous system (CNS) lymphoma or a history of CNS lymphoma at the time of recruitment;
- •There are obvious gastrointestinal diseases at the time of screening, which may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
- •Pregnant, lactating women and patients of childbearing age who are unwilling to take contraceptive measures;
- •Subjects with lymphoma and leukemia (proportion of malignant tumor cells in bone marrow examination> 20%) Circumstances judged by other investigators to be inappropriate to participate in this study. -
研究组 & 干预措施
Mitoxantrone liposome combined with Chidamide and Azacitidine
Experimental
干预措施: Mitoxantrone liposome、Chidamide、Azacitidine (Drug)
结局指标
主要结局
ORR
时间窗: one year
objective response rate
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
Modified BEAM Regimen for T Cell Lymphoma Underwent ASCTAutologous Stem Cell TransplantationConditioningNCT05814718First Affiliated Hospital Xi'an Jiaotong University122
尚未招募
2 期
Mitoxantrone Hydrochloride Liposome Combined With Rituximab and Lenalidomide (M+R2) in Patients With Relapsed and Refractory Diffuse Large B-Cell LymphomaDiffuse Large B-cell LymphomaNCT05575973Jianfeng Zhou55
招募中
1 期
Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Relapsed/Refractory Multiple MyelomaRelapsed/Refractory Multiple MyelomaNCT05857982Second Affiliated Hospital of Soochow University20
招募中
2 期
Mitoxantrone Hydrochloride Liposome Injection in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)Diffuse Large B-Cell LymphomaNCT05875428CSPC ZhongQi Pharmaceutical Technology Co., Ltd.104
招募中
2 期
Mitoxantrone Hydrochloride Liposome in Combination With Cytarabine and Venetoclax Regimen in Newly Diagnosed Elderly AMLAcute Myeloid LeukemiaNCT06621199First Affiliated Hospital of Zhejiang University42