EUCTR2008-000053-35-NL进行中（未招募）不适用
A phase II study to assess engraftment and engraftment kinetics after double cord blood transplantation with a reduced-intensity conditioning regimen in patients eligible for allogeneic stem cell transplantation lacking a matched unrelated donor - engraftment after double cord blood transplantation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Erasmus MC
- 入组人数
- 40
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
- •Age 65 years old or younger. High risk disease as specified in protocol. Lacking a sufficiently matched volunteer unrelated donor or lacking such a donor within the required timeperiod of no more than 2 months in case of urgently needed alloSCT. Availability of 2 sufficiently matched UCB grafts with a total nulear cell count > 4 x 10 7/kg.
- •Are the trial subjects under 18? no
- •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
- •Bilirubin and/of transaminases > 2.5 x normal value. Creatinine clearance < 40 ml/min. Active, uncontrolled infection. Cardiac dysfunction. Pulmonary dysfunction test with VC, FEV1 and/of DCO < 50%. History of high/dose total body irradiation. HIV positivity.
研究者
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A phase II study to assess engraftment and engraftment kinetics after double cord blood transplantation with a reduced-intensity conditioning regimen in patients eligible for allogeneic stem cell transplantation lacking a matched unrelated donor.Patients with high-risk hematological malignancies (acute myeloid leukemia, acute lymphoblastic leukemia or myelodysplastic syndrome with high-risk characteristicschronic myeloid leukemia in second chronic phase(very) severe aplastic anemia relapsing after or failing immunosuppressive therapyNon-Hodgkin lymphoma or chronic lymphocytic leukemia, responsive at (at least) third line chemotherapy) meeting the criteria for allogeneic matched unrelated donor transplantation but lacking a sufficiently matched volunteer donorNL-OMON26715Erasmus Medical Centre RotterdamDepartment of Hematology40
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