Avatrombopag for the Primary Prevention of Thrombocytopenia Induced by Cytarabine-based Chemotherapy in Patients With Lymphoma: An Open, Single-center, Phase II Randomized Controlled Clinical Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- The incidence of grades III and IV thrombocytopenia
研究概览
简要总结
This phase 2 trial studies the efficacy and safety of Avatrombopag for the primary prevention of thrombocytopenia induced by cytarabine-based chemotherapy in patients with lymphoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed lymphoma;
- •Patients are scheduled to receive cytarabine-based chemotherapy including Ara-C at dose of 4g/m
- •Eastern Cooperative Oncology Group (ECOG) of 0-1;
- •Proper functioning of the major organs: 1) The absolute value of neutrophils (>1.5×10^9/L); platelet count (> 100×10^9/L); Hemoglobin (> 90 g/L); 2) Serum total bilirubin < 1.5 times ULN; Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) < 3 times ULN;3) Serum creatinine <1.5 times Upper Limit Normal (ULN) ; 4) Coagulation function: International Normalized Ratio (INR), Prothrombin Time (PT)< 1.5 times ULN
- •Able to use oral drugs
- •Patients volunteer to sign an informed consent
- •Life expectancy > 3 months;
- •Contraceptives are used
排除标准
- •Thrombocytopenia unrelated to chemotherapy during six months before screening, including but not limited to hypersplenism, infection and hemorrhage.
- •In addtion to CIT caused by lymphoma and chemotherapy,patients also suffer from other blood diseases including ALL, AML, myeloid neoplasms, MDS, myeloproliferative disorders, MM;
- •A thrombosis of a coronary artery or vein developed during three months before screening;
- •Haemorrhage with severe clinical symptoms, such as gastrointestinal and cerebral hemorrhage;
- •Platelet transfusion during two days before randomization;
- •Allergic to avatrombopag;
- •Participation in any other research about novel agents or devices;
- •Pregnant or breastfeeding women;
- •Researchers consider it unsuitable for patients to participate in this study.
研究组 & 干预措施
blank control
No intervention aiming at preventing thrombocytopenia will be taken after first cycle. Avatrombopag as salvage treatment will be administered to patients suffering from thrombocytopenia with nadir platelet count < 50 × 109/L at a dose of 60mg/day until there is drug-withdrawal indication.
干预措施: avatrombopag (Drug)
primary prevention
As the primary prevention of thrombocytopenia induced by cytarabine-based chemotherapy, Avatrombopag will be administered at a dose of 60mg/day on days -3~-1 and 3~9, for a total of 10 doses. On the condition that patients have platelet counts <50 × 10 9 /L before next cycle, Avatrombopag will be administered at a dose of 60mg/day until there is drug-withdrawal indications. Platelet transfusions were administered to patients when the platelet count was less than 10×109 /L.
Drug-withdrawal indications:
PLT ≥ 100×109/L during salvage treatment or platelet count increases by 50×109/L, comparing with baseline level.
When platelet count is higher than 400×109/L during this study, researchers determine whether avatrombopag is discontinued
干预措施: avatrombopag (Drug)
结局指标
主要结局
The incidence of grades III and IV thrombocytopenia
时间窗: 2 years
次要结局
- The durations of any grade thrombocytopenia and grades II, III and IV thrombocytopenia(2 years)
研究者
Qingqing Cai
Chief physician
Sun Yat-sen University