Discontinuation of Imatinib Mesylate in Patients With Chronic-Phase Chronic Myeloid Leukemia Previously Treated With Interferon-Alpha
2016年11月11日 更新者:University of Michigan Rogel Cancer Center
Discontinuation of Tyrosine Kinase Inhibitor Therapy in Patients With Chronic-Phase Chronic Myeloid Leukemia, Previously Treated With Interferon-Alpha
To investigate whether patients with chronic-phase chronic myeloid leukemia (CP-CML) previously treated with interferon-alpha (IFN) and presently on a tyrosine kinase inhibitor (TKI) (imatinib mesylate, dasatinib, or nilotinib) with achievement of a complete cytogenetic and at least a major molecular remission, are able to discontinue therapy and maintain a durable remission.
Relapse-free survival (RFS) rate at 1 year after discontinuation of TKI will be the measurement of this objective.
研究概览
研究类型
观察性的
注册 (实际的)
7
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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Michigan
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Ann Arbor、Michigan、美国、48109
- University of Michigan Cancer Center
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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 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
取样方法
非概率样本
研究人群
Diagnosed with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia in chronic phase.
描述
Inclusion Criteria:
- Patients must have a diagnosis of Philadelphia chromosome positive (Ph+) chronic myeloid leukemia in chronic phase.
- Patients must have received prior therapy with interferon-alpha for their CML, for a period of at least 2 years, and achieved at least a partial cytogenetic response on this therapy, defined as 1% - 34% Ph+ cells in metaphase, present in the bone marrow.
- Patients must be actively receiving treatment for their CML with a TKI (imatinib mesylate, dasatinib, nilotinib). If patients are receiving dasatinib or nilotinib, this can only be for reasons other than imatinib-resistant CML.
Patients must have an ongoing complete hematologic response (CHR) on a TKI, defined as follows:
- WBC ≤ 10 x 109/L.
- Platelet count < 450,000 x 109/L.
- No blasts or promyelocytes in peripheral blood.
- No evidence of disease-related symptoms and extramedullary disease, including the liver and spleen.
- Patients must have a complete cytogenetic response (CCyR) on a TKI for a minimum of one year leading up to enrollment. Complete cytogenetic response is defined as 0% Ph+ cells in metaphase, in the bone marrow and/or a negative peripheral blood FISH analysis for the BCR/ABL gene fusion, and an ongoing CCyR must be confirmed by bone marrow aspirate cytogenetics and/or peripheral blood FISH for BCR/ABL within 4 weeks of discontinuing therapy.
- Patients must have at least a major molecular remission on a TKI for a minimum of 1 year, present on 2 consecutive analyses, performed at least 3 months apart, in the 6 to 12 months leading up to enrollment. Major molecular remission is defined as ≥ 3 log reduction from a standard baseline value (equivalent to a BCR-ABL/ABL of ≤ 0.1%) in BCR/ABL transcript by quantitative RT-PCR performed on peripheral blood or bone marrow aspirate. Complete molecular remission is defined as a negative quantitative RT-PCR (QPCR) analysis for BCR/ABL, present on 2 consecutive analyses, performed at least 3 months apart, in the 6 to 12 months leading up to enrollment.
- Patients must be eighteen years of age or older
- Patients must have an ECOG performance status of 0-2 (Appendix 13.1)
- All patients must be informed of the investigational nature of this study and standard alternative therapy. All patients must sign and give written informed consent in accordance with institutional and federal guidelines.
Exclusion Criteria:
- Patients who have had prior progression of their CML to accelerated phase or blast crisis.
- Patients who have previously undergone hematopoietic stem cell transplantation.
- Patients receiving dasatinib or nilotinib due to a prior history of imatinib-resistant CML.
- Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable.
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
队列和干预
团体/队列 |
干预/治疗 |
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Discontinuation
Subjects who agree to discontinue their tyrosine kinase inhibitor(TKI)therapy, namely,imatinib mesylate, dasatinib, or nilotinib,and then followed to see if they can maintain a durable remission.
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Patients with chronic-phase chronic myeloid leukemia (CP-CML) previously treated with interferon-alpha (IFN) and presently on a tyrosine kinase inhibitor (TKI) (imatinib mesylate, dasatinib, or nilotinib) with achievement of a complete cytogenetic and at least a major molecular remission.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Relapse-free survival
大体时间:1 year
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Relapse-free survival (RFS) rate at 1 year after discontinuation of TKI will be the measurement of this objective.
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1 year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Reduction of the malignant stem cell population
大体时间:1 Year
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To determine whether prior treatment with interferon-alpha followed by TKI therapy effectively depletes/reduces the malignant stem cell population in CP-CML.
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1 Year
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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。
调查人员
- 首席研究员:Dale Bixby, M.D./PhD、University of Michigan Rogel Cancer Center
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5月1日
初级完成 (实际的)
2011年11月1日
研究完成 (实际的)
2011年11月1日
研究注册日期
首次提交
2010年2月19日
首先提交符合 QC 标准的
2010年2月22日
首次发布 (估计)
2010年2月23日
研究记录更新
最后更新发布 (估计)
2016年11月15日
上次提交的符合 QC 标准的更新
2016年11月11日
最后验证
2016年11月1日
更多信息
与本研究相关的术语
关键字
- 知情同意
- diagnosis of Ph+) CML in chronic phase.
- prior therapy with interferon-alpha for at least 2 years, and achieved at least a partial cytogenetic response
- receiving a TKI (imatinib mesylate, dasatinib, nilotinib)
- WBC ≤ 10 x 109/L.
- Platelet count < 450,000 x 109/L.
- No blasts or promyelocytes in peripheral blood.
- No evidence of disease-related symptoms and extramedullary disease
- complete cytogenetic response (CCyR) on a TKI for a minimum of 1 yr
- major molecular remission on a TKI for a minimum of 1 yr
- 18 years of age or older
- ECOG performance status of 0-2 (Appendix 13.1)
其他相关的 MeSH 术语
其他研究编号
- UMCC 2008.083
- HUM00021950 (其他标识符:University of Michigan Medical IRB)
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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