NCT06559553招募中1 期
A Prospective Clinical Study of "Selinexor+Pegaspargase+Dexamethasone" in the Treatment of Stage Ⅰ/Ⅱ NK/ T-Cell Lymphoma
Mingzhi Zhang1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- CRR
研究概览
简要总结
evaluate the efficacy and safety of "Selinexor+pegaspargase+dexamethasone" in early stage NK/ T-cell lymphoma
详细描述
Patients with early NK/T cell lymphoma were treated with an oral regimen of "Selinisol + pemaspartase + dexamethasone"
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years old, ECOG score 0-2; (including those aged 18 and 70);
- •Pre-survival time > 6 months;
- •The pathological tissue was confirmed as NK/T cell lymphoma (the pathological report of the first three months of enrollment could be accepted) (Note: If there is any doubt about the pathological diagnosis, domestic third-party consultation could be organized);
- •Clinical stage Ⅰ to Ⅱ (CA stage) with at least one measurable lesion;
- •Acceptable hematological indicators, no contraindications to chemotherapy; Neutrophil absolute value ≥1.0×10^9 /L, platelet ≥75×10^9 /L, hemoglobin ≥80g/L (except patients with lymphoma bone marrow infiltration);
- •Liver function: direct bilirubin ≤1.5× upper limit reference value; Glutamic pyruvic transaminase or glutamic oxalacetic transaminase ≤2.5× upper limit reference value; Alkaline phosphatase ≤3×ULN in non-bone invaded patients;
- •Renal function: serum creatinine ≤1.5×ULN;
- •Female and male patients of reproductive age and their spouses are willing to use adequate contraception throughout the study period, and female patients of reproductive age must have a negative serum pregnancy test within 7 days before the first dose;
- •The newly treated patient had not received other tumor-related treatment in the past;
- •Subjects voluntarily participate in the clinical trial, sign informed consent, and cooperate with follow-up;
排除标准
- •Refuse to collect blood samples;
- •Previous allergy to any of the drugs in the program;
- •Pregnant and lactating women;
- •Major diseases that the investigator believes can cause interference with the test;
- •Combined with other tumors;
- •There are contraindications related to therapeutic drugs in the program;
- •Persons with serious mental illness;
- •Participating in other clinical trials;
- •Previous anti-tumor therapy (such as radiotherapy, chemotherapy, hormone therapy, biotherapy, immunotherapy);
- •Other serious medical conditions that may limit participants' participation in the trial, such as uncontrolled diabetes; Severe cardiac insufficiency (NYHA grade II or above); Acute coronary syndrome within the last 6 months; Coronary revascularization such as stenting, coronary artery bypass surgery, and other heart and large vessel related procedures within the last 6 months; Severe arrhythmias include frequent ventricular early, ventricular tachycardia, rapid atrial fibrillation/flutter, and severe bradycardia. Uncontrolled hypertension: systolic blood pressure >150mmHg, diastolic blood pressure >100mmHg. Gastric ulcers (stomach ulcers that researchers have determined are at risk of perforation); Active autoimmune diseases (e.g. systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia, etc.); Severe respiratory disease (such as obstructive pulmonary disease and a history of bronchospasm);
- •Hemophagic cell syndrome;
- •Researchers do not consider it suitable for inclusion;
- •Hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal reference value range; Hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA positive; Human immunodeficiency virus (HIV) antibody positive; Syphilis test positive.
研究组 & 干预措施
Selinexor+pegaspargase+dexamethasone
Experimental
Nuclear export protein-1 is the main transporter protein for leucine-rich proteins to enter the cytoplasm from the nucleus through the nuclear pore complex, which is overexpressed in malignant tumor cells. Studies have shown that Selinexor inhibits the nuclear export of viral mRNA such as EBV, and has good therapeutic potential for NKTCL. Selinexor combined with pemaspartase, dexamethasone and sequential radiotherapy may be the golden choice for early NK/T cell lymphoma, improving the local control rate of the disease and improving the overall prognosis of NK/T cell lymphoma.
干预措施: Selinexor+pegaspargase+dexamethasone (Drug)
结局指标
主要结局
CRR
时间窗: From date of randomization until the date tumor volume has reduced, assessed up to 36 months
The proportion of patients whose tumor volume has reduced to a predetermined value and can maintain the minimum time limit is the sum of complete mitigation.
次要结局
未报告次要终点
研究者
Mingzhi Zhang
the director of oncology department of the first affiliated hospital
Zhengzhou University
研究点 (1)
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