NCT00861874已完成1 期
A Phase I Study of Decitabine in Combination With Escalating Doses of Rapamycin in Patients With Relapsed or Refractory Acute Myeloid Leukemia
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
- 13
- 试验地点
- 1
- 主要终点
- Evaluate the safety of chemotherapy with the drug decitabine combined with rapamycin to determine the highest dose of rapamycin that can be given in combination with decitabine.
研究概览
简要总结
The purpose of this study is to determine the safety and feasibility of the combination of decitabine given at a fixed dose with escalating doses of rapamycin in patients with relapsed or refractory acute myeloid leukemia.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 18 years
- •Diagnosis of AML according to WHO criteria except acute promyelocytic leukemia AND
- •Refractory AML defined as a failure to achieve CR after 2 cycles of induction chemotherapy or persistence of > 40% bone marrow blasts after one cycle of chemotherapy induction OR
- •Relapsed AML defined as any evidence of disease recurrence within 12 months of achieving first CR OR
- •Relapsed AML after stem cell transplantation 100 days must have elapsed between transplant and emergence of recurrent AML
- •ECOG performance status <3 (Appendix 1)
排除标准
- •Abnormal renal function as evidenced by a calculated creatinine clearance ≤ 30ml/min (Cockcroft-Gault formula (Appendix 2)
- •Abnormal liver function: Bilirubin >2.0 mg/dl, transaminase more than 2.5x the upper limits of normal
- •Active systemic infection
- •Known chronic liver disease
- •Known diagnosis of human immunodeficiency virus infection (HIV)
- •Patients who are post-allogeneic transplantation should not have active GVHD greater than grade 1 of skin
- •Pregnant or breast feeding female subjects
研究组 & 干预措施
Treatment
Experimental
干预措施: Decitabine (Drug)
Treatment
Experimental
干预措施: Rapamycin (Drug)
结局指标
主要结局
Evaluate the safety of chemotherapy with the drug decitabine combined with rapamycin to determine the highest dose of rapamycin that can be given in combination with decitabine.
时间窗: 6 months
次要结局
未报告次要终点
研究者
Jane Liesveld
Professor of Medicine, Hematology and Bone Marrow Transplant
University of Rochester
研究点 (1)
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