The Efficacy and Toxicity of GDP Chemotherapy in Patients With Peripheral T-cell Lymphoma: An Open-label, Single-arm, Phase II Clinical Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- overall response rate
研究概览
简要总结
This study is to evaluate the efficacy and safety of GDP (gemcitabine, dexamethasone, and cisplatin) chemotherapy in patients with peripheral T-cell lymphoma-NOS as frontline treatment.
详细描述
Peripheral T-cell lymphomas,not otherwise specified constitutes 25.9% of Peripheral T-cell lymphomas and over 15% of all lymphomas by the World Health Organization classification. Because of the rare presentation and evident heterogeneity of PTCL-NOS, optimal frontline therapy for this disease in the modern era remains unclear. Patients have traditionally been treated with anthracycline-containing chemotherapy such as CHOP or CHOP-like regimen used in B-cell NHLs. This strategy is associated with an overall response rate higher than 60%, but the 5-year PFS and OS rates have been reported to be as low as approximately 20-30%.Better therapeutic regimens are in highly need to improve the survival outcome of these patients. The investigators' previous study reported an ORR of 64% in relapsed/refractory PTCL-NOS patients. Therefore, the investigators design this study to evaluate the efficacy and safety of GDP chemotherapy as frontline treatment in patients with PTCL-NOS.
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
- •histological and imaging diagnosis of PTCL-NOS based on immunophenotypic and morphologic criteria according to the 2008 World Health Organization classification of lymphomas;
- •newly-diagnosed patients with no prior systemic chemotherapy or stem-cell transplantation treatment.
- •age ≥ 18 years;
- •life expectancy of more 3 months;
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
- •at least one measurable lesion;
- •adequate hematologic, hepatic, and renal functions: absolute neutrophil count ≥ 1.5×109/l, platelet count ≥ 100×109/l, total bilirubin ≤ 1.5 × upper limit of normal, AST and ALT ≤ 2 × upper limit of normal, and creatinine ≤ 1.5 mg/dl;
- •informed consent.
排除标准
- •patients who received prior treatment;
- •pregnant or breastfeeding women and women of childbearing potential not employing adequate contraception;
- •patients with second primary cancer (except, adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥5 years)
- •patients with defect of central nervous system (CNS) or any psychiatric disorders and CNS metastases
- •other serious illness or medical conditions A. Clinically significant cardiac disease (uncontrolled congestive heart disease despite treatment [NYHA class III or IV], symptomatic coronary artery disease, unstable angina or myocardial infarction, conduction abnormality like grade 2 AV block, serious arrhythmia needed for medication, uncontrolled hypertension) within 6 months prior to study entry B. Liver cirrhosis (≥ Child-Pugh class B) C. History of significant neurologic or psychiatric disorders including dementia or seizures D. Active uncontrolled infection E. Other serious underlying medical conditions which could impair the ability of the patient to participate in the study
研究组 & 干预措施
GDP chemotherapy
GDP chemotherapy: gemcitabine (1000mg/m2 intravenously over 30 minutes on days 1 and 8), cisplatin (25mg/m2 intravenously over 60 minutes on days 1-3), and dexamethasone (20mg/d orally on days 1-4 and days 11-14), which was administered every 21 days.
干预措施: GDP chemotherapy (Drug)
结局指标
主要结局
overall response rate
时间窗: 4-6 cycles
次要结局
- 2-year progression-free survival(2 year)
- 2-year overall survival(2 year)
- number of patients with adverse events(2 year)
研究者
Mei Dong
chief physician
Chinese Academy of Medical Sciences