Study on Avatrombopag for the Promotion of Platelet Engraftment After Allogeneic Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percentage of participants whose PLT reaches ≥ 20*10^9/L without the need for PLT transfusion.
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of avatrombopag for the promotion of platelet engraftment after Allo-HSCT.
详细描述
Patients with thrombocytopenia (PLT<20×10^9/L) after allogenic hematopoietic stem cell transplantation (Allo-HSCT) who meet Eligibility Criteria were assigned into the avatrombopag group for 4 weeks' treatment.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged between 18-60 years;
- •PLT<20×10^9/L after 14 days of allo-HSCT;
- •Expected survival time > 3 months;
- •ECOG performance status 0-2;
- •Agree to receive the treatment of avatrombopag after Allo-HSCT and must sign the informed consent form.
排除标准
- •Pregnant or lactating;
- •With severe and uncontrollable infection;
- •With graft-versus-host disease (GVHD) with steroid resistance;
- •With thrombotic microangiopathy; With active thromboembolism requiring anticoagulation
- •With detected disease recurrence due to chimerism by flow cytometry;
- •With chronic active hepatitis B and C virus infection;
- •With secondary or multiple transplantation, or multiple organ transplantation;
- •With severe heart disease, lung disease, diabetes and metabolic diseases;
- •HIV positive;
- •With a history of PLT dysfunction or bleeding disorders
- •With the active hepatic venous occlusion disease, or a history of clinically significant hepatic venous occlusion disease (The disease was defined as the abnormal condition of painful hepatomegaly after transplantation with bilirubin ≥ 6.0 mg/dL);
- •With progressive solid tumor;
- •With severe bleeding requiring transfusion of more than 2 units of red blood cells, or sudden drop of blood cell volume ≥10% within 7 days prior to screening;
- •With any other clinical trial of investigational product or device within 30 days prior to the baseline visit, except for observational study;
- •With treatment of thrombopoietin receptor agonist (TPO-RA) one month before enrollment;
- •Deemed unsuitable for enrollment by the investigator.
研究组 & 干预措施
Avatrombopag
In the 4-weeks'study,the initial dose of avatrombopag is 20 mg/d. If the patient's PLT count remains less than 20*10^9/L after one week, the maximum dose was increased to 40 mg/d. Avatrombopag will be taken orally with food.
干预措施: Avatrombopag (Drug)
Supportive care
Patients in this arm receive same treatment as in the avatrombopag group,except any TPO-RAs or recombinant human thrombopoietin.
干预措施: Supportive care (Other)
结局指标
主要结局
Percentage of participants whose PLT reaches ≥ 20*10^9/L without the need for PLT transfusion.
时间窗: up to 4 weeks
Accumulated platelet engraftment ratio
次要结局
- Volume of PLT transfusion(up to 4 weeks)
- Hematopoietic reconstruction condition(up to 4 weeks)
- Percentage of participants whose PLT reaches ≥ 50*10^9/L without the need for PLT transfusion.(up to 4 weeks)
- The time to achieve PLT ≥ 20*10^9/L without the need of PLT transfusion for consecutive 7 days (Defined as the first day when PLT ≥ 20×10^9/L without relying on platelet transfusion for 7 consecutive days )(up to 4 weeks)
研究者
HAN Yue
Director of hematology department
The First Affiliated Hospital of Soochow University