EUCTR2009-011817-26-BE进行中（未招募）1 期
A pilot study to assess the feasibility of unrelated umbilical cord blood transplantation with coinfusion of third-party mesenchymal stem cells after myeloablative or nonmyeloablative conditioning in adult patients with hematological malignancies.
Z Brussel VUB0 个研究点目标入组 20 人开始时间: 2009年9月28日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patient inclusion criteria:
- •Age 15-60 yrs with following diseases
- •Allogeneic stem cell transplantation is the preferred treatment option:
- •High risk acute myeloid leukemia (AML) in first complete remission (CR)
- •High risk acute lymphoblastic leukemia (ALL) in first CR
- •Acute leukemia in second or third remission
- •High risk myelodysplastic syndrome: IPSS Intermediate-2 or high risk
- •Advanced lymphoproliferative disorders
- •Chronic myeloid leukemia
- •Multiple myeloma
- •Informed consent given
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patient exclusion criteria
- •Previous allogeneic transplant
- •Progressive malignant disease
- •Significant organ damage as a contraindication to allotransplantation
- •Creatinine clearance < 60 ml/min
- •AST/ALT > 3x normal value and/or serum bilirubin > 3 mg/dL
- •Cardiac failure (LVEF < 50%)
- •Clinical relevant pulmonary disease: DLCO < 50% normal
- •Significant psychiatric or neurological disorder
- •Uncontrolled viral, fungal or bacterial infection
- •HIV positive
研究者
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