NCT00943319已完成1 期
A Phase I-II Study of Busulfan-fludarabine Conditioning and T-cell Depleted Allogeneic Stem Cell Transplantation for Patients With Advanced Hematologic Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose
研究概览
简要总结
The purpose of this study is:
- To establish the maximally tolerated dose (MTD) of intravenous busulfan (Busulfan®) in combination with fludarabine as conditioning regimen for transplantation with in-vivo T-cell depletion.
- To evaluate disease free and overall survival after this conditioning regimen in patients with advanced acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS).
- To evaluate potential pharmacogenomic determinants of toxicity of this regimen.
- To evaluate potential pharmacogenomic determinants of efficacy of this regimen.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Phase I portion:
- •Relapsed or refractory acute myelogenous or lymphoid leukemia.
- •Chronic myelogenous leukemia in accelerated phase or blast-crisis.
- •Recurrent or refractory malignant lymphoma or Hodgkin's disease
- •Recurrent or refractory multiple myeloma.
- •Chronic lymphocytic leukemia, relapsed or with poor prognostic features.
- •Myeloproliferative disorder (polycythemia vera, myelofibrosis) with transformation
- •Myelodysplastic syndromes with more than 5% blasts.
- •Phase II portion:
- •AML with active disease or beyond CR
- •MDS with more than 5% blasts.
排除标准
- •Clinical progression. Such patients may be treated on other treatment protocols or at the investigator's discretion. Such patients will continue to be monitored for survival and, may be asked to continue to provide specimens for studies of minimal residual disease and immune reconstitution as other treatments are recommended.
研究组 & 干预措施
Busulfan and fludarabine
Experimental
Intravenous busulfan (Busulfan®) in combination with fludarabine
干预措施: Busulfan (Drug)
Busulfan and fludarabine
Experimental
Intravenous busulfan (Busulfan®) in combination with fludarabine
干预措施: Fludarabine (Drug)
Busulfan and fludarabine
Experimental
Intravenous busulfan (Busulfan®) in combination with fludarabine
干预措施: Campath (Drug)
Busulfan and fludarabine
Experimental
Intravenous busulfan (Busulfan®) in combination with fludarabine
干预措施: Stem Cell Transplant (Procedure)
结局指标
主要结局
Maximum Tolerated Dose
时间窗: 5 years
Maximally tolerated area under the curve of intravenous busulfan (Busulfan®) in combination with fludarabine as conditioning regimen for transplantation with in-vivo T-cell depletion. The number reported will be an Area Under the Curve (AUC) measure reported in µmol-min/L.
次要结局
- Disease Free Survival(5 years)
- Overall Survival(5 years)
研究者
研究点 (1)
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