NCT02323178已完成1 期
A Phase I/II Study of Eltrombopag in Patients With Chronic Myelomonocytic Leukemia and Thrombocytopenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 26
- 主要终点
- Platelet response
研究概览
简要总结
Treatment of patients with chronic myelomonocytic leukemia (CMML) and thrombocytopenia.
详细描述
All eligible patients will be treated with eltrombopag for a minimum of twelve weeks and a maximum of 24 months.
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
- •Age 18 years or older
- •Chronic myelomonocytic leukemia (CMML) according to WHO criteria:
- •Stable excess in blood monocytes > 1 G/L
- •Lack of bcr-abl rearrangement (or Philadelphia chromosome)
- •Bone marrow blast cells < 20%
- •Dysplasia of at least one lineage or clonality marker or blood monocytosis during more than 3 months w/o other explanation
- •Platelet counts < 50 G/L on two successive blood counts in the 2 weeks preceding inclusion
- •Either of D1 or D2 criteria:
- •Lack of features of advanced disease If white blood cell count (WBC) < 13 G/L: International Prognostic Scoring System (IPSS) low or intermediate-1
- •If WBC ≥ 13 G/L: no more than one of the following criteria:
- •Clonal cytogenetic abnormality other than t(5;12) (q33; p13)
- •Absolute neutrophil count (ANC) > 16 G/L
- •Anemia (Hb < 100 g/L)
- •Extramedullary localization (documented cutaneous, pleural or pericardial effusion, etc...) OR D2- Features of advanced disease If WBC < 13 G/L: IPSS intermediate-2 or high
- •If WBC ≥ 13 G/L: two or more of the following criteria:
- •Clonal cytogenetic abnormality other than t(5;12) (q33; p13)
- •ANC > 16 G/L
- •Anemia (Hb < 100 g/L)
- •Extramedullary localization (documented cutaneous, pleural or pericardial effusion, etc...) And having resisted (progression or stable disease without hematological improvement according to International Working Group (IWG) 2006 criteria) or relapsed after a treatment with a hypomethylating agent (azacitidine or decitabine for a minimum of 6 cycles)
- •Blast cells ≤ 5% in the bone marrow
- •Performance status 0-2 on the Eastern Cooperative Oncology Group (ECOG) Scale
- •Serum Creatinin < 2 times the upper limit of normal (ULN)
- •Alanine transaminase (ALT) and aspartate transaminase (AST) < 3 ULN, total bilirubin < 1.5 ULN (except Gilbert Syndrome)
- •Adequate contraception if relevant
- •Signed informed consent
排除标准
- •CMML with t(5 ;12) or Platelet-derived growth factor beta receptor (PDGFbetaR) rearrangement
- •Acute blastic transformation of CMML with bone marrow blast cells > 20%
- •Bone marrow blast cells > 5%
- •Patients eligible for allogeneic bone marrow transplantation with an identified donor
- •Intensive chemotherapy given less than 3 months before inclusion
- •Pregnant or breastfeeding
- •Hepatitis C infection
- •Splenomegaly > 16 cm by ultrasound or CT scan (Not Applicable in patients without palpable splenomegaly)
- •Significant (grade II-IV) myelofibrosis (bone marrow trephine if bone marrow aspirate with poor cellularity, or features of myelofibrosis on the peripheral blood smear (teardrop erythrocytes)
- •Clinically relevant thromboembolic risk factor which, in the investigator's opinion, is such that the benefit/risk ratio becomes unfavourable if platelet counts increase
- •Liver cirrhosis (Child-Pugh score ≥ 5)
- •Prior Cancer (except in situ cervix carcinoma, limited basal cell carcinoma, or other tumors if not active during the last 3 years)
- •Serious concomitant systemic disorder, including active bacterial, fungal or viral infection that, in the opinion of the investigator, would compromise the safety of the patient and/or his/her ability to complete the study.
- •Hypersensitivity to Eltrombopag
研究组 & 干预措施
eltrombopag
Experimental
干预措施: eltrombopag (Drug)
结局指标
主要结局
Platelet response
时间窗: 12 weeks
Hematological improvement after twelve weeks of eltrombopag treatment
次要结局
- Duration of platelet response(30 months)
研究者
研究点 (26)
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