SCH 727965 in Patients With Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia (P04717AM2)(TERMINATED)
2015年2月3日 更新者:Merck Sharp & Dohme LLC
A Phase 2 Study of SCH 727965 in Subjects With Relapsed and Refractory Acute Myelogenous Leukemia and Acute Lymphoblastic Leukemia
Participants with acute myelogenous leukemia (AML) will be randomized to SCH 727965 or gemtuzumab ozogamicin.
All participants with acute lymphoblastic leukemia (ALL) will receive SCH 727965.
Part 1 of the study will determine the activity of SCH 727965 treatment in participants with AML and participants with ALL.
Part 2 of the study will determine the activity of SCH 727965 treatment in participants with AML who experienced disease progression after standard treatment with gemtuzumab ozogamicin during Part 1.
研究概览
研究类型
介入性
注册 (实际的)
29
阶段
- 阶段2
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 及以上 (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:
For participants with AML:
- Age >=60 years, either sex, any race.
- Diagnosis of CD33-positive AML by World Health Organization criteria.
- Must be in first or second relapse, or have primary refractory or refractory disease at first salvage, and not be considered a candidate for transplant.
- Acute promyelocytic leukemia who has relapsed following treatment with both all trans retinoic acid (tretinoin) and arsenic trioxide-based therapy is eligible.
For participants with ALL:
- Age >=18 years, either sex, any race.
- Diagnosis of ALL by World Health Organization criteria.
- Must be in first or second relapse, or have primary refractory or refractory disease at first salvage, and not be considered a candidate for potentially curative therapy.
- Eastern Cooperative Oncology group performance status of 0 or 1.
- Adequate hematologic, renal, and hepatic organ function and laboratory parameters.
- Receiving treatment with hydroxyurea or leukapheresis to reduce elevated white blood cell count to <=30 x 10^9 is eligible, provided hydroxyurea and leukapheresis are discontinued at least 24 hours before initiation of study drug.
Exclusion Criteria:
- Known central nervous system leukemia.
- Previous hematopoietic stem cell transplantation.
- Previous treatment with SCH 727965 or other cyclin-dependent kinase inhibitors.
- For AML, previous treatment with gemtuzumab ozogamicin.
- Known HIV infection.
- Known active hepatitis B or C.
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:Participants with AML randomized to SCH 727965
|
SCH 727965 50 mg/m2 IV on Day 1 of each 21 day cycle until disease progression.
|
有源比较器:Participants with AML randomized to gemtuzumab ozogamicin
|
Gemtuzumab ozogamicin 9 mg/m2 IV on Day 1 and Day 15.
其他名称:
|
实验性的:AML treated w/ SCH 727965 after prog. on gemtuzumab ozogamicin
|
SCH 727965 50 mg/m2 IV on Day 1 of each 21 day cycle until disease progression.
|
实验性的:Participants with ALL treated with SCH 727965
|
SCH 727965 50 mg/m2 IV on Day 1 of each 21 day cycle until disease progression.
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Overall response rate of initial treatment with SCH 727965 in subjects with AML or ALL.
大体时间:Time to identified response or disease progression on SCH 727965 in Part 1 (approx. 5 months).
|
Time to identified response or disease progression on SCH 727965 in Part 1 (approx. 5 months).
|
Overall response rate in participants with AML treated with SCH 727965 after disease progression on comparator.
大体时间:Time to identified response or disease progression on SCH 727965 in Part 2 (approx. 5 months).
|
Time to identified response or disease progression on SCH 727965 in Part 2 (approx. 5 months).
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Time to disease progression for initial treatment with SCH 727965 in subjects with AML or ALL.
大体时间:Time to identified disease progression on SCH 727965 in Part 1 (approx. 5 months).
|
Time to identified disease progression on SCH 727965 in Part 1 (approx. 5 months).
|
Overall response rate and time to progression of treatment with gemtuzumab ozogamicin in subjects with AML.
大体时间:Time to identified response or disease progression on gemtuzumab ozogamicin (approx. 5 months).
|
Time to identified response or disease progression on gemtuzumab ozogamicin (approx. 5 months).
|
Time to disease progression for treatment with gemtuzumab ozogamicin in participants with AML.
大体时间:Time to identified disease progression on gemtuzumab ozogamicin (approx. 5 months).
|
Time to identified disease progression on gemtuzumab ozogamicin (approx. 5 months).
|
Time to disease progression in participants with AML treated with SCH 727965 after disease progression on gemtuzumab ozogamicin
大体时间:Time to identified disease progression on SCH 727965 in Part 2 (approx. 5 months).
|
Time to identified disease progression on SCH 727965 in Part 2 (approx. 5 months).
|
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
2009年1月1日
初级完成 (实际的)
2010年4月1日
研究完成 (实际的)
2010年4月1日
研究注册日期
首次提交
2008年11月25日
首先提交符合 QC 标准的
2008年11月25日
首次发布 (估计)
2008年11月26日
研究记录更新
最后更新发布 (估计)
2015年2月4日
上次提交的符合 QC 标准的更新
2015年2月3日
最后验证
2015年2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.
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