NCT00491634已完成2 期
Phase II Trial of Fludarabine Combined With Intravenous Treosulfan and Allogeneic Hematopoietic Stem-cell Transplantation in Patients With Chemo-refractory or Previously Untreated Acute Myeloid Leukemia and Myelodysplastic Syndrome.
Dr. Avichai Shimoni MD1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2007年6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
- 24
- 试验地点
- 1
- 主要终点
- disease-free survival
研究概览
简要总结
The study hypotheses is that the introduction of dose escalated treosulfan, in substitution to busulfan, will reduce toxicity after allogeneic transplantation while improving myeloablation and and disease control in patients with AML and MDS not eligible for standard transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age less than physiologic 68 years.
- •Patients with AML and MDS not eligible for standard TBI- or Busulfan-based myeloablative conditioning due to age, concurrent medical condition, or extensive prior therapy (e.g. age > 55 years for HLA-matched sibling transplants or > 50 for matched unrelated donor transplants, prior / concomitant pulmonary, liver, or other organ complications).
- •This study will only include patients with chemo-refractory disease or previously untreated active disease.
- •A. acute myeloid leukemias (AML) according to WHO classification (> 20% myeloblasts in peripheral blood or bone marrow at diagnosis) in induction failure, PR, untreated or chemo-refractory relapse. Patients must have > 10% marrow blasts at the time of transplantation.
- •B. myelodysplastic syndromes (MDS) according to WHO classification (< 20% myeloblasts in peripheral blood and bone marrow at diagnosis), indicated for allogeneic transplantation:
- •refractory anaemia with excess blasts (RAEB-1 and RAEB-2) with no prior therapy
- •Patients must have an HLA matched related or unrelated donor willing to donate either peripheral blood stem cells or bone marrow. Matching is based on high-resolution class I (HLA-A, -B, -C) and class II (HLA-DRB1, -DQB1) typing. The goal is to transplant > 3 x 106 CD34+ cells per kg body weight of the recipient -
排除标准
- •Bilirubin > 3.0 mg/dl, transaminases > 3 times upper normal limit
- •Creatinine > 2.0 mg/dl
- •ECOG-Performance status > 2
- •Uncontrolled infection
- •Pregnancy or lactation
- •Abnormal lung diffusion capacity (DLCO < 40% predicted)
- •Severe cardiovascular disease
- •CNS disease involvement
- •Pleural effusion or ascites > 1 liter
- •Known hypersensitivity to fludarabine or treosulfan
- •Psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate -
研究组 & 干预措施
1
Experimental
treosulfan
干预措施: Treosulfan (Drug)
结局指标
主要结局
disease-free survival
时间窗: 2 years after transplantation
次要结局
- treatment-related mortality, GVHD, relapse, overall survival(2 year after transplantation)
研究者
Dr. Avichai Shimoni MD
Dr. Avichai Shimoni
Sheba Medical Center
研究点 (1)
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