A Single-arm, Phase 2 Study of Sintilimab, Pegaspargase Combined with Gemcitabine and Oxaliplatin (P-P-GEMOX) Regimen for Newly Diagnosed Extranodal NK/T-Cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Complete response rate (CRR)
研究概览
简要总结
This is a single-arm phase 2 study designed to evaluate the safety and efficacy of sintilimab, pegaspargase combined with gemcitabine and oxaliplatin (P-P-GEMOX regimen) as first-line treatment for patients with ENKTL. The primary endpoint is the complete response rate (CRR) in the intention-to-treat population.The secondary endpoints were overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and adverse events.
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
- •Histopathologically confirmed diagnosis of extranodal NK/T-cell lymphoma (ENKTL) by the study center.
- •Age between 18 and 75 years.
- •At least one of the following risk factors: Age ≥ 60 years; Presence of B symptoms; ECOG performance status ≥ 2; Elevated lactate dehydrogenase (LDH); Baseline EBV-DNA > 500 copies/mL.
- •ECOG performance status of 0 to
- •Adequate bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L (≥ 1.0 × 10⁹/L in cases with bone marrow involvement); Platelet count (PLT) ≥ 80 × 10⁹/L (≥ 50 × 10⁹/L in cases with bone marrow involvement); Hemoglobin (HGB) ≥ 80 g/L.
- •Adequate organ function: Alanine aminotransferase (ALT) < 3 × the upper limit of normal (ULN); Total bilirubin (TBil) < 1.5 × ULN; Serum creatinine < 1.5 × ULN; NYHA heart function class 0-2; Left ventricular ejection fraction (LVEF) > 50%.
排除标准
- •Aggressive NK-cell leukemia.
- •Central nervous system lymphoma.
- •History of any of the following within 6 months: Acute myocardial infarction; Unstable angina; Congestive heart failure; Uncontrolled symptomatic arrhythmia; Complete left bundle branch block; Second- or third-degree atrioventricular block; Long QT syndrome or corrected QT interval (QTc) > 480 ms.
- •Uncontrolled active infection.
- •Pregnant or breastfeeding women.
研究组 & 干预措施
P-P-GemOx arm
Sintilimab, pegaspargase combined with gemcitabine and oxaliplatin (P-P-GEMOX) regimen
干预措施: Immunochemotherapy (Drug)
结局指标
主要结局
Complete response rate (CRR)
时间窗: Responses were evaluated after 3 cycles of induction and 1 month after the completion of study therapy (each cycle is 21 days)
Treatment responses were assessed according to the 2014 Lugano classification criteria.
次要结局
- Progression-free survival (PFS)(From date of enrollment until documented disease progression or death of any reason (up to 3 years).)
- Overall survival(From date of enrollment until documented death of any reason (up to 3 years).)
- Overall response rate(Responses were evaluated after 3 cycles of induction and 1 month after the completion of study therapy (each cycle is 21 days).)
- Adverse event(From enrollment till 28 days post the last induction cycle.)