A Randomized Controlled Clinical Trial of Apatinib Combined With CHOP Regimen in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Apatinib Combined With CHOP Regimen(cyclophosphamide, vincristine, epirubicin, prednisone in the treatment of newly diagnosed peripheral T-cell lymphoma.
详细描述
Patients with peripheral T-cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional CHOP regimen. Apatinib is a small-molecule multitargeted tyrosine kinase inhibitor. The investigators have been proceeding this trial to evaluate the efficacy and safety of the Apatinib Combined With CHOP Regimen(cyclophosphamide, vincristine, epirubicin, prednisone in the treatment of newly diagnosed peripheral T-cell lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range 14-70 years old; ECOG performance status 0-
- •Estimated survival time > 6 months.
- •Histological confirmed Peripherial T-cell lymphoma.
- •Have taken no treatment.
- •None of chemotherapy contraindication: hemoglobin ≥ 90 g/dl, neutrophil ≥ 1.5×109/L, platelet ≥ 100×109/L, ALT and AST ≤ 2×ULN, serum bilirubin ≤ 1.5×ULN, serum creatine ≤ 1.5×upper limitation of normal (ULN), Serum Albumin ≥ 30g/L, serum plasminogen is normal.
- •At least one measurable lesion.
- •None of other serious diseases, cardiopulmonary function is normal.
- •Pregnancy test of women at reproductive age must be negative.
- •Patients could be followed up.
- •None of other relative treatments including the traditional Chinese medicine, immunotherapy, biotherapy except anti-bone metastasis therapy and other symptomatic treatments.
- •Volunteers who signed informed consent.
排除标准
- •Patients with contraindications (active bleeding, ulcers, intestinal perforation, intestinal obstruction, 30 days after major surgery, hypertension uncontrollable drugs, grade III-IV cardiac insufficiency, severe liver and kidney dysfunction);
- •Abnormal coagulation (INR > 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5 ULN), with bleeding tendency or undergoing thrombolysis or anticoagulant therapy；
- •Urine routine indicates urinary protein ≥ ++, or confirmed 24-hour urine protein ≥ 1.0 g;
- •Disagreement on blood sample collection.
- •Patients allergic of any of drug in this regimen or with metabolic disorder.
- •Pregnant or lactating women.
- •Serious medical illness likely to interfere with participation.
- •Serious infection.
- •Primitive or secondary tumors of central nervous system.
- •Chemotherapy or radiotherapy contraindication.
- •The evidence of CNS metastasis.
- •History of peripheral nervous disorder or dysphrenia.
- •Patients participating in other clinical trials.
- •Patients taking other antitumor drugs.
- •Patients estimated to be unsuitable by investigator.
研究组 & 干预措施
Apatinib combined with CHOP regimen
Apatinib: 250mg/d d1-21 po CHOP regimen(Cyclophosphamide,Vincristine,Epirubicin,Prednisone) ： Cyclophosphamide 750mg/d,ivgtt, d1;Vincristine,1.4g/m2,ivgtt, d1;Epirubicin,60mg/m2,ivgtt,d1;Prednisone 60mg/m2,po, d1-5
干预措施: Apatinib (Drug)
Apatinib combined with CHOP regimen
Apatinib: 250mg/d d1-21 po CHOP regimen(Cyclophosphamide,Vincristine,Epirubicin,Prednisone) ： Cyclophosphamide 750mg/d,ivgtt, d1;Vincristine,1.4g/m2,ivgtt, d1;Epirubicin,60mg/m2,ivgtt,d1;Prednisone 60mg/m2,po, d1-5
干预措施: CHOP Regimen (Drug)
CHOP regimen
CHOP regimen(Cyclophosphamide,Vincristine,Epirubicin,Prednisone) ： Cyclophosphamide 750mg/d,ivgtt, d1;Vincristine,1.4g/m2,ivgtt, d1;Epirubicin,60mg/m2,ivgtt,d1;Prednisone 60mg/m2,po, d1-5
干预措施: CHOP Regimen (Drug)
结局指标
主要结局
PFS
时间窗: up to end of follow-up-phase (approximately 24 months)
Progression-free survival
RR
时间窗: every 6 weeks, up to completion of treatment (approximately 18 weeks)
Response Rate
次要结局
- OS(up to the date of death (approximately 5 years))
研究者
Mingzhi Zhang
the director of oncology department of the first affiliated hospital
Zhengzhou University