Apatinib for Relapsed and Refractory Difuse Large B Cell Lymphoma: an Open-label, Single Armed, Exploratory Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Overall Response Rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Apatinib for patients with Relapsed Refractory Diffuse Large B Cell Lymphoma.
详细描述
Patients with relapsed /refractory diffuse large B cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional chemotherapy of CHOP. Apatinib is a new type of oral tyrosine kinase inhibitor targeting VEGFR-2.The investigators have been proceeding this trial to evaluate the efficacy and safety of Apatinib in the patients with relapsed refractory diffuse large B cell lymphoma.
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
- 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 diffuse large B cell lymphoma.
- •Have taken first-line chemotherapy regimen and failed.
- •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
- •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
Apatinib 500mg once daily makes an initial dose and 28 days made one treatment cycle. All patients took the drug continuously until disease progression, intolerable toxicities, and patient-requested withdrawal. Appropriate supportive care were given.
干预措施: Apatinib (Drug)
结局指标
主要结局
Overall Response Rate
时间窗: up to end of follow-up-phase
The proportion of patients whose tumor volume has reduced to a predetermined value and can maintain the minimum time limit is the sum of complete and partial mitigation.
次要结局
- Progression-free Survival(up to end of follow-up-phase)
- Overall Survival(up to the date of death or end of follow-up-phase)
研究者
Mingzhi Zhang
the director of oncology department of the first affiliated hospital
Zhengzhou University