A Phase II Trial of Eltrombopag for Patients With Chronic Lymphocytic Leukemia (CLL) and Thrombocytopenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Number of Participants With a Response
研究概览
简要总结
The goal of this clinical research study is to learn if eltrombopag can help to increase the number of platelets in patients with CLL. The safety of this drug will also be studied.
详细描述
The Study Drug:
When the number of platelets in your body gets too low, it can cause bleeding, which may cause serious health problems and/or prevent you from receiving chemotherapy. Eltrombopag is designed to act like a protein in your body that helps make platelets. This may help increase your platelet counts.
Study Drug Administration:
You will take pills of the study drug by mouth 1 time each day on an empty stomach (1 hour before or 2 hours after a meal). You should take the pills with 1 cup (8 ounces) of water. You should wait at least 4 hours between taking eltrombopag and eating foods with calcium (dairy products and/or juices with added calcium) or taking drugs/supplements with iron, calcium, aluminum, magnesium, selenium and/or zinc. Other drugs may also affect eltrombopag. Be sure to tell your doctor about any drugs and/or supplements you may be taking.
During your study visits, your doctor will check your platelet counts to see if they improve. If they do not improve, your dose of study drug may be increased. Your doctor will instruct you on each dose of eltrombopag you should take.
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
- •Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
- •Age >/= 18 years
- •PLT transfusion-dependent, defined as need for transfusion to maintain PLT count >/=20K/µL, or the average of two (non-transfused) PLT counts taken within 2 weeks of the screening period </=50K/µL, with no individual count >55K/µL
- •Patients with ITP must have failed at least 1 prior treatment for ITP including one of the following: corticosteroids, rituximab, splenectomy, cyclosporine
- •At least 3 weeks must have elapsed since the last chemotherapy treatment for CLL
- •ECOG performance status (PS) </=2
- •Adequate liver function (total bilirubin </=2* upper limit normal (ULN); ALT </=2.5* ULN)
- •Adequate renal function (serum creatinine Cr </=2.2 mg/dL)
- •For patients with ITP on corticosteroids or cyclosporine, dose of corticosteroids or cyclosporine must be stable for 2 weeks prior to enrollment and planned to be tapered in patients responding to eltrombopag
- •Able to provide informed consent
排除标准
- •Concurrent chemotherapy for CLL
- •Diagnosis of Richter's transformation
- •Uncontrolled autoimmune hemolytic anemia i.e. patients with AIHA that is not controlled with treatment such as corticosteroids or cyclosporine. This would include patients who require PBRC transfusions or who do not have a stable hemoglobin (HGB) due to ongoing hemolysis.
- •Concurrent treatment for ITP (except for corticosteroids and cyclosporine)
- •Diagnosis of myelodysplastic syndrome or acute myeloid leukemia
- •Active infection or significant medical illness as determined by the treating physician
- •Treatment with thrombomimetic agents in the past 3 months (rTPO, PEG-rHuMGDF, Nplate or Promacta)
- •Pregnant or breast feeding subjects and subjects not willing to use adequate contraceptive precautions
研究组 & 干预措施
Eltrombopag
Starting dose 75 mg by mouth (PO) daily for 28 day cycle.
干预措施: Eltrombopag (Drug)
结局指标
主要结局
Number of Participants With a Response
时间窗: Up to 4 years
Response is Complete Response (CR) + Major Response (MR). Complete response was defined as an increase in platelet count to ≥100K/µL for at least 4 weeks. Major response was defined as an increase in platelet count from \<20K/µL to ≥20K/μL and by at least 100% for at least 8 weeks; or for pts starting with \>20K/μL platelet count, absolute increase in platelet count of ≥30K/μL for at least 4 weeks.
次要结局
- Time to CLL Progression Requiring Leukemia Treatment(Up to 4 years)