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临床试验/NCT01268800
NCT01268800Unknown不适用

Rapid Profiling of Bone Marrow, at Presentation and After 5 Days of Induction Therapy, a Sensitive Method for Identifying Resistant AML Clones

Rambam Health Care Campus1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年2月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
complete remission

研究概览

简要总结

Personalization of AML therapy, require a reliable mechanism for accurate characterization of patient specific leukemia phenotype and genotype. Patient's specific leukemic phenotype or in practical clinical term, patient's leukemia sensitivity to induction therapy, should best investigated in-vivo during induction. Elimination of circulating leukemic blasts from peripheral blood by day 5 was shown to discriminate between good responders with superior long term survival and poor responders with poor outcome. However, many AML patients have no circulating blasts at diagnosis and even in those who have, elimination rate of it from peripheral blood was never correlated with actual response in bone marrow.

Currently, the only available source for patient's specific leukemia profile, is the bone marrow sample at diagnosis. Since leukemic blasts are heterogeneous and come from multiple different clones, "on diagnosis" marrow consist a spectrum of chemotherapy sensitive and resistance clones. Clones may vary by their molecular abnormalities and results from "on diagnosis" marrow may overlook minor resistant but existing clones. Long term prognosis is determined by those resistant clones and though our interests should be focused into the abnormalities of these clones. Residual blasts on day 5 marrow may better represent the profile of patient's leukemic resistant clones.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of acute myeloid leukemia other than APL
  • Age > 18
  • Patient's considered by their physician "fit" for intensive induction therapy

排除标准

  • Withdrawal of informed consent or inability to consent
  • Previous allogeneic transplantation.
  • One of the following lab values persistent from presentation to day 5:
  • Serum creatinine > 2mg/dl, Direct bilirubin > 2mg/dl
  • SGOT (AST) > x4 upper limit of normal
  • Left ventricular ejection fraction < 40% as assessed 2-D echocardiogram
  • Coagulation abnormalities (INR > 1.6, PTT > x1.5 normal range)

结局指标

主要结局

complete remission

时间窗: 30-54 days

Bone marrow blasts \<5% upon recovery from induction therapy

次要结局

  • Overall survival(two years)
  • relapse rate(two years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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