IV Plerixafor With Mitoxantrone Etoposide and Cytarabine for Acute Myeloid Leukemia (AML) (AML)
2015年1月21日 更新者：Washington University School of Medicine
A Phase I Study of Intravenous Plerixafor in Combination With Mitoxantrone Etoposide and Cytarabine for Relapsed or Refractory Acute Myeloid Leukemia
In this phase I extension study, the investigators seek to test the safety of both higher doses of plerixafor as well as intravenous dosing to maximize inhibition of the target, CXCR4.
研究概览
详细说明
In this study, we are seeking to target the leukemia microenvironment to overcome disease resistance.
We hypothesize that by disrupting the interaction of leukemic blasts with the bone marrow microenvironment, we may sensitize leukemic blasts to the effects of cytotoxic chemotherapy.
In current formulations, the volume of plerixafor required to administer doses higher than 240 mcg/kg may result in significant discomfort with repeated daily injections.
In this phase I extension study, we seek to test the safety of both higher doses of plerixafor as well as intravenous dosing to maximize inhibition of the target, CXCR4.
研究类型
介入性
注册 (实际的)
6
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Missouri
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St. Louis、Missouri、美国、63110
- Washington University School of Medicine
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
Acute myeloid leukemia diagnosed according to WHO criteria with one of the following:
- Primary refractory disease following ≥ 1 round of induction chemotherapy
- First relapse or higher
- Age between 18 and 70 years
- ECOG performance status ≤ 2
Adequate organ function defined as:
- Creatinine ≤ 1.5 x institutional ULN
- AST ≤ 2 x ULN except when in the opinion of treating physician is due to direct involvement of leukemia (e.g., hepatic infiltration or biliary obstruction due to leukemia)
- ALT ≤ 2 x ULN except when in the opinion of treating physician is due to direct involvement of leukemia (e.g., hepatic infiltration or biliary obstruction due to leukemia)
- Total bilirubin ≤ 2 x ULN except when in the opinion of treating physician is due to direct involvement of leukemia (e.g., hepatic infiltration or biliary obstruction due to leukemia)
- Left ventricular ejection fraction of ≥ 40% by MUGA scan or echocardiogram
- Women of childbearing potential and sexually active males must be willing and able to use effective contraception while on study
- Able to provide signed informed consent prior to registration on study
Exclusion Criteria:
- Acute promyelocytic leukemia (AML with t(15;17)(q22;q11) and variants)
- Peripheral blood blast count ≥ 50 x 103 /mm3
- Active CNS involvement with leukemia
- Previous treatment with MEC or other regimen containing both mitoxantrone and etoposide
- Pregnant or nursing
- Concurrently receiving any other investigational agent
- Received colony stimulating factors filgrastim or sargramostim within 48 hours or pegfilgrastim within 14 days of study
- Less than 2 weeks from the completion of any previous cytotoxic chemotherapy (excluding hydroxyurea)
- Severe concurrent illness that would limit compliance with study requirements
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Dose Level 1
Mitoxantrone 8 mg/m2/day IV over 30 minutes once daily on days 1-5 Plerixafor 320 mcg/kg/day IV over 30 minutes on days 0-5 Etoposide 100 mg/m2/day IV over 60 minutes once daily on days 1-5 Cytarabine 1000 mg/m2/day IV over 60 minutes once daily on days 1-5 |
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实验性的：Dose Level 2
Mitoxantrone 8 mg/m2/day IV over 30 minutes once daily on days 1-5 Plerixafor 420 mcg/kg/day IV over 30 minutes on days 0-5 Etoposide 100 mg/m2/day IV over 60 minutes once daily on days 1-5 Cytarabine 1000 mg/m2/day IV over 60 minutes once daily on days 1-5 |
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实验性的：Dose Level 3
Mitoxantrone 8 mg/m2/day IV over 30 minutes once daily on days 1-5 Plerixafor 560 mcg/kg/day IV over 30 minutes on days 0-5 Etoposide 100 mg/m2/day IV over 60 minutes once daily on days 1-5 Cytarabine 1000 mg/m2/day IV over 60 minutes once daily on days 1-5 |
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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To determine the maximum tolerated dose and dose limiting toxicities of intravenous plerixafor when combined with MEC in patients with relapsed or refractory AML.
大体时间：Days 1-42 (all patients have to complete)
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Days 1-42 (all patients have to complete)
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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To determine the complete response rate (CR) for plerixafor when combined with MEC in patients with relapsed or refractory AML.
大体时间：Between days 15-42
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Between days 15-42
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To determine the safety and tolerability of plerixafor in combination with MEC
大体时间：Minimum of 30 days following completion of treatment
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Minimum of 30 days following completion of treatment
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To determine the PK and explore potential PK drug-drug interactions between plerixafor and MEC.
大体时间：Predose, 15 min, 30 min , and 10 hrs
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Predose, 15 min, 30 min , and 10 hrs
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To determine the time to hematologic recovery
大体时间：For up to 2 years
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For up to 2 years
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To characterize the mobilization of leukemic cells with plerixafor plus G-CSF.
大体时间：Baseline, 6 hours
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Baseline, 6 hours
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To characterize the effects of plerixafor plus G-CSF on SDF-1/CXCR4 signaling on leukemic blasts.
大体时间：Baseline, 6 hours
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Baseline, 6 hours
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To determine the time to overall survival
大体时间：For up to 2 years
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For up to 2 years
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To determine the time to event-free survival
大体时间：For up to 2 years
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For up to 2 years
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To determine the time to duration of remission
大体时间：For up to 2 years
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For up to 2 years
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To determine the time to relapse-free survival
大体时间：For up to 2 years
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For up to 2 years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年5月1日
初级完成 (实际的)
2010年7月1日
研究完成 (实际的)
2011年9月1日
研究注册日期
首次提交
2009年12月7日
首先提交符合 QC 标准的
2009年12月8日
首次发布 (估计)
2009年12月9日
研究记录更新
最后更新发布 (估计)
2015年1月26日
上次提交的符合 QC 标准的更新
2015年1月21日
最后验证
2015年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.