NCT02179359终止不适用
MT2014-10C: Allogeneic Hematopoietic Stem Cell Transplant for Patients With High Risk Hemoglobinopathies and Other Red Cell Transfusion Dependent Disorders
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- incidence of graft failure
研究概览
简要总结
This is a study to collect the outcomes of stem cell transplantation for patients with hematologic diseases other than cancer.
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
- — 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Sickle Cell Disease, Thalassemia, Diamond Blackfan Anemia or other non-malignant hematologic disorders for which a stem cell transplant is indicated
- •Acceptable stem cell source identified
- •Performance status of ≥ 70% (Karnofsky),or ≥ 70 (Lansky play score)
- •Creatinine <2.0 mg/dl for adults or glomerular filtration rate > 50 ml/min for children
- •Bilirubin, Aspartate Aminotransferase, Alkaline phosphatase <5 times the upper limit of institutional normal
- •Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction > 40%
排除标准
- •active, uncontrolled infection
- •pregnant or breastfeeding
- •HIV positive
研究组 & 干预措施
Reduced Toxicity Ablative Regimen
Experimental
For use in patients with a matched sibling donor or unrelated UCB donor and DBA patients who are <12 years and/or have mild/moderate iron exposure.
干预措施: Reduced Toxicity Ablative Regimen (Drug)
Reduced Intensity Preparative Regimen
Experimental
For use in patients with unrelated donor bone marrow and for DBA patients who are >12 years and/or have significant iron exposure.
干预措施: Reduced Intensity Preparative Regimen (Drug)
Myeloablative Preparative Regimen
Experimental
For use in patients with a matched sibling donor, unrelated umbilical cord blood and in those with severe thalassemia.
干预措施: Myeloablative Preparative Regimen (Drug)
结局指标
主要结局
incidence of graft failure
时间窗: 42 days
次要结局
- overall survival(6 months, 1 and 2 years)
- disease free survival(6 months, 1 and 2 years)
研究者
研究点 (1)
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