Gemcitabine, Pegaspargase, Etoposide, and Dexamethasone (GPED) for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma : a Single Arm,Open-lable,Phase II Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- 2-year progression free survival (PFS) rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of gemcitabine, pegaspargase, etoposide, and dexamethasone (GPED) in the treatment of Relapsed/Refractory or advanced NK/T-cell lymphoma patients (ENKTCL).
详细描述
Pegaspargase is the cornor stone for the treatment of ENKTCL, and gemcitabine has been shown to be active in ENKTCL. For several patients with relapsed/refractory or advance ENKTCL, hemophagocytic sysdrome (HPS) occurs, and the prognosis is very poor. Studies have found that etoposide and dexamethasone may be effective in controlling HPS. Thus, this study aims to evaluate the role of gemcitabine, pegaspargase, etoposide, and dexamethasone (GPED) in the treatment of relapsed/refractory or advance ENKTCL, wishing to improve the prognosis for these patients.
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
- •Histopathology and immunohistochemistry confirmed diagnosis of NK/Tcell lymphoma according to WHO 2016 criteria.
- •refractory or relapsed after initial remission, or stage III-IV de novo patients
- •PET/CT or CT/MRI with at least one objectively evaluable lesion.
- •General status ECOG score 0-3 points.
- •The laboratory test within 1 week before enrollment meets the following conditions:
- •Blood routine: Hb>80g/L, PLT>50×10e9/L.
- •Liver function: ALT, AST, TBIL ≤2 times the upper limit of normal.
- •Renal function: Cr is normal.
- •Cardiac function: LVEF≥50%, ECG does not suggest any acute myocardial infarction, arrhythmia or atrioventricular conduction above I Blocking.
- •Sign the informed consent form
排除标准
- •Active infection requires ICU treatment. Concomitant HIV infection or active infection with HBV, HCV. Patients who are infected with HBV but not active hepatitis at the same time are notexcluded.
- •Significant organ dysfunction Pregnant and lactating women.
- •Those who were known to be allergic to drugs in the study regimen.
- •Patients with other tumors who require surgery or chemotherapy within 6 months.
- •Other experimental drugs are being used.
研究组 & 干预措施
treatment arm
gemcitabine 1.25g/㎡ d1, pegaspargase 2500IU/㎡ d1 (max dose =<3750IU) etoposide 75mg/㎡ d1-3 dexamethasone 20mg d1-4 repeated every 21 days, up to 6 cycles.
干预措施: gemcitabin (Drug)
treatment arm
gemcitabine 1.25g/㎡ d1, pegaspargase 2500IU/㎡ d1 (max dose =<3750IU) etoposide 75mg/㎡ d1-3 dexamethasone 20mg d1-4 repeated every 21 days, up to 6 cycles.
干预措施: Pegaspargase (Drug)
treatment arm
gemcitabine 1.25g/㎡ d1, pegaspargase 2500IU/㎡ d1 (max dose =<3750IU) etoposide 75mg/㎡ d1-3 dexamethasone 20mg d1-4 repeated every 21 days, up to 6 cycles.
干预措施: Etoposide (Drug)
treatment arm
gemcitabine 1.25g/㎡ d1, pegaspargase 2500IU/㎡ d1 (max dose =<3750IU) etoposide 75mg/㎡ d1-3 dexamethasone 20mg d1-4 repeated every 21 days, up to 6 cycles.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
2-year progression free survival (PFS) rate
时间窗: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
PFS is defined as date of enrollment to date of disease progression, relapse, death of any reason, or last follow-up, whichever comes first.
次要结局
- Overall response rate (ORR)(evaluated every 2 cycles of treamtent, up to one month after the end of treatment)
- Complete response rate (CRR)(evaluated every 2 cycles of treamtent, up to one month after the end of treatment)
- 2-year overall survial (OS) rate(From date of enrollment until the date of death from any cause or last follow-up, assessed up to 24 months)
研究者
JING-WEN WANG
Director of department of hematology
Beijing Tongren Hospital