A Phase II Study of Dexamethasone, Azacitidine, Pegaspargase and Tislelizumab Plus Radiotherapy for Patients With Stage I/II Extranodal NK/T-cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 57
- 试验地点
- 3
- 主要终点
- Complete response rate
研究概览
简要总结
The goal of this clinical trial is to learn if the regimen of dexamethasone, azacitidine, pegaspargase and tislelizumab (DAPT regimen) combined with radiotherapy works to treat stage I or II NK/T cell lymphoma in adults. It will also learn about the safety of the DAPT regimen. The main questions it aims to answer are:
What are the efficacy of the DAPT regimen plus radiotherapy in participants with extranodal NK/T-cell lymphoma? What medical problems do participants have when taking the DAPT regimen?
Participants will:
Receive the DAPT regimen every 21 days for 6 cycles and radiotherapy Visit the clinic according to clinical trial requirement for checkups and tests Receive blood tests and radiological imaging tests according to the clinical trial requirement
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
- •Pathologically confirmed diagnosis of extranodal NK/T-cell lymphoma
- •Age ≥18 years
- •Ann Arbor stage I or II
- •Presence of at least 1 measurable lesion according to the 2014 Lugano revised criteria for response assessment
- •ECOG-PS 0~2
- •Peripheral blood absolute neutrophil count ≥1.5×10E9/L, platelet count ≥75×10E9/L and hemoglobin ≥90g/L
- •Expected survival of at least 3 months
- •Capable of understanding the content of this study, agreeing to participate in this study and signing the informed consent.
排除标准
- •Unconfirmed pathological diagnosis of NK/T-cell lymphoma
- •Pregnant or lactating women, or patients of childbearing age unwilling to take contraceptive measures during the study period.
- •Patients with clinically significant prolonged QTc interval (>470ms in males, >480ms in females), ventricular tachycardia, atrial fibrillation, second or third degree atrioventricular block, acute myocardial infarction, congestive heart failure, severe or symptomatic coronary artery disease requiring medical treatment.
- •Patients with large amount of pericardial effusions shown by echocardiogram.
- •Patients who received supportive care for anemia, neutropenia or thrombocytopenia within 7 days prior to start of study treatment.
- •Patients with severe active bleeding.
- •Patients with pulmonary embolism, intracranial hemorrhage or acute cerebral infarction.
- •Patients with active infectious disease.
- •Patients who are mentally disabled or unable to understand or sign the informed consent form.
- •Patients with other conditions judged as ineligible for this study by the investigators.
研究组 & 干预措施
DAPT regimen plus radiotherapy
Patients receive 6 cycles of DAPT regimen plus concurrent radiotherapy. The DAPT regimen consists of dexamethasone, azacitidine, pegaspargase and tislelizumab.
干预措施: DAPT regimen plus radiotherapy (Drug)
结局指标
主要结局
Complete response rate
时间窗: From enrollment to the end of treatment at 8 weeks
Complete response rate is assessed according to the 2014 Lugano criteria for response assessment of lymphoma.
次要结局
- Objective response rate(From enrollment to the end of treatment at 8 weeks)
- 2-year progression-free survival rate(From enrollment to 2 years after the end of treatment)
- 2-year overall survival rate(From enrollment to 2 years after the end of treatment)
- Adverse events(From enrollment to the end of treatment at 1 month)