NCT01795677已完成2 期
JAK2 Inhibitors RUXOLITINIB in Patients With High or Intermediate Risk Primary or Secondary Myelofibrosis Eligible for Allogeneic Stem Cell Transplantation: a Prospective Multicentric Phase II Study
French Innovative Leukemia Organisation1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2012年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- DFS
研究概览
简要总结
JAK2 inhibitor RUXOLITINIB before allogeneic hematopoietic stem cell transplantation (HSCT) in patients with primary or secondary myelofibrosis : a prospective phase II
详细描述
JAK2 inhibitor RUXOLITINIB before allogeneic hematopoietic stem cell transplantation (HSCT) in patients with primary or secondary myelofibrosis
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 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 69 years
- •No comorbidity contraindicating the transplantation :
- •Severe respiratory failure defined as dyspnea grade III or more
- •Severe cardiac failure defined as EF < or = 30%
- •Severe renal failure defined as creatinine clearance < 30 ml/min or dialysis
- •Dementia or non-ability to give informed consent for the protocol
- •Major alteration of performance status defined as ECOG > 2
- •Severe liver disease defined as a cirrhosis or bilirubin > 2 x ULN, or AST/ALT > 5 x ULN
- •Primary or secondary myelofibrosis diagnosed according to WHO definition (Tefferi, et al 2007)
- •Palpable splenomegaly or splenomegaly measured by any imagery (maximum size> 15 cm by ultrasound scan, Magnetic Resonance Imaging or computer tomography)
- •Disease if intermediate or high risk according to published criteria and summarized as follows:
- •At least one criterion among the following:
- •Haemoglobin < 100 gr/L (unrelated to medication toxicity)
- •Leucocytes < 4 G/L (unrelated to medication toxicity) or > 25 G/L
- •Poor prognosis cytogenetics : complex karyotype, abnormalities of chromosomes 5, 7 or 17 , +8, 12p-, inv(3), 11q23
- •Two criteria among the following criteria :
- •General symptoms (weight lost > 10% in less than 6 months, night swears, specific fever > 37.5°C)
- •Peripheral blastosis > 1% observed at least twice
- •Thrombocytopenia < 100 G/L (unrelated to treatment toxicity)
排除标准
- •Myelofibrosis transformed into acute leukaemia with 20% blasts of more in blood or bone marrow
- •Previous treatment with JAK2 inhibitor
- •Thrombopenia < 50 G/L
- •Comorbidities contraindicating the transplantation
- •Comorbidity score Sorror > 3
- •Pregnant or lactating women
研究组 & 干预措施
RUXOLOTINIB
Experimental
Ruxolotinib : patient with donor HSCT 4 months later patients without donor: ruxolotinib alone
干预措施: Ruxolotinib (Drug)
结局指标
主要结局
DFS
时间窗: 24 months after inclusion
DFS is defined as the probability to be alive and in remission
次要结局
- PATIENTS CARACTERISTICS(24 months after inclusion)
- HSCT(24 months after inclusion)
研究者
研究点 (1)
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