NCT00986804已完成1 期
Maintenance Therapy With Decitabine After Allogeneic Stem Cell Transplantation for Acute Myelogenous Leukemia and High-Risk Myelodysplastic Syndrome
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
- 24
- 试验地点
- 1
- 主要终点
- To determine the maximum tolerated dose and schedule of decitabine when administered as maintenance therapy after alloHSCT performed for AML or high-risk MDS.
研究概览
简要总结
Primary:
To determine the maximum tolerated dose and schedule of decitabine when administered as maintenance therapy after allogeneic hematopoietic stem cell transplantation (alloHSCT) performed for AML or high-risk MDS.
详细描述
Secondary:
- To determine the safety and tolerability of decitabine as maintenance therapy after alloHSCT.
- To determine the rates disease relapse, 1-year disease-free survival, and overall survival.
- To assess lymphoid and myeloid chimerism while on decitabine maintenance.
- To determine the incidence of acute and chronic GVHD.
- To assess immunologic reconstitution after alloHSCT.
- To assess changes in gene expression and methylation patterns following decitabine treatment
- To assess the effects of decitabine on immune reconstitution post transplant.
- To access the frequency of FoxP3+ CD3+/CD4+ and CD3+/CD8+ lymphocytes before and after decitabine treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Level 1
Experimental
Decitabine 5.0 mg/m2/day on Days 1 thru 5 every 6 weeks for as many as 8 cycles.
干预措施: Decitabine (Drug)
Level 2
Experimental
Decitabine 7.5 mg/m2/day on Days 1 thru 5 every 6 weeks for as many as 8 cycles.
干预措施: Decitabine (Drug)
Level 3
Experimental
Decitabine 10.0 mg/m2/day on Days 1 thru 5 every 6 weeks for as many as 8 cycles.
干预措施: Decitabine (Drug)
Level 4
Experimental
Decitabine 15.0 mg/m2/day on Days 1 thru 5 every 6 weeks for as many as 8 cycles.
干预措施: Decitabine (Drug)
结局指标
主要结局
To determine the maximum tolerated dose and schedule of decitabine when administered as maintenance therapy after alloHSCT performed for AML or high-risk MDS.
时间窗: Up to 6 weeks (completion of first cycle)
次要结局
- To assess immunologic reconstitution after alloHSCT.(End of study (42 weeks))
- To determine overall survival.(Every 3 months for 2 years then every 6 months for 3 years)
- To assess lymphoid and myeloid chimerism while on decitabine maintenance.(End of cycle 3 (18 weeks))
- To determine the incidence of acute GVHD.(End of study (42 weeks))
- To determine the rates disease relapse(Every 3 months for 2 years then every 6 months for 3 years)
- To access the frequency of FoxP3+ CD3+/CD4+ and CD3+/CD8+ lymphocytes before and after decitabine treatment.(End of cycle 3 (18 weeks))
- To determine the 1-year disease-free survival(1 year)
- To determine the safety and tolerability of decitabine as maintenance therapy after alloHSCT.(Up to 30 days after end of study (approximately 46 weeks))
- To assess changes in gene expression and methylation patterns following decitabine treatment(End of study (42 weeks))
- To assess the effects of decitabine on immune reconstitution post transplant.(End of study (42 weeks))
- To determine the incidence of chronic GVHD.(End of study (42 weeks))
研究者
研究点 (1)
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