NCT00980018已完成4 期
An Exploratory Trial to Assess the Improvement of Chronic Low-grade Non-hematologic Adverse Events Experienced by Patients With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Treated With Imatinib When Switched to Nilotinib Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 20
- 主要终点
- Percentage of Participants With Improvement in Imatinib Related Chronic Low Grade Non Hematologic Adverse Event (AE) After Switch to Treatment With Nilotinib at End of Cycle 3
研究概览
简要总结
The purpose of this exploratory study will be to examine changes in chronic low grade chronic adverse events, measured by Common Terminology Criteria for Adverse Events (CTCAE) grading, when patients are switched from imatinib to nilotinib therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Male or female patients ≥ 18 years of age
- •Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2
- •Diagnosis of CML-CP associated with Bcr-Abl quantifiable by RQ-PCR (IS)
- •Patients must be an imatinib responder and achieved the following efficacy milestones as appropriate for the length of time on imatinib therapy as per protocol
- •CML-CP patients initiated on any dose of imatinib
- •Ability to provide written informed consent prior to any study related screening procedures being done
排除标准
- •Loss of CHR or cytogenetic response
- •Prior accelerated phase or blast phase CML
- •Previously documented T315I mutation
- •Presence of chromosomal abnormalities (trisomy 8) and/or clonal evolution other than Ph+.
- •Previous treatment with any other tyrosine kinase inhibitor except for imatinib.
- •Treatment with other investigational agents within 30 days of Day
- •History of non-compliance to medical regimens or inability to grant consent.
- •Women who are pregnant, breast feeding, or of childbearing potential without a negative serum test at baseline. Male or female patients of childbearing potential unwilling to use contraceptive precautions throughout the trial and 3 months following discontinuation of study drug. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Women of childbearing potential must have a negative serum pregnancy test prior to the first dose of nilotinib.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
nilotinib
Experimental
Participants received two 150 [a total of 300 mg at each dosing] mg nilotinib capsules twice daily (bid) orally every morning and every evening approximately 12 hours apart and two 200 mg capsules [a total of 400 mg at each dosing] for patients enrolled prior to Protocol Amendment 1).
干预措施: Nilotinib (Drug)
结局指标
主要结局
Percentage of Participants With Improvement in Imatinib Related Chronic Low Grade Non Hematologic Adverse Event (AE) After Switch to Treatment With Nilotinib at End of Cycle 3
时间窗: End of Cycles 1, 2, and 3
A patient was considered improved if 50% or more of the chronic imatinib-related chronic low grade nonhematologic AEs showed improvement (a decrease in CTCAE \[Common Terminology Criteria for Adverse Events\] grade or complete resolution).
次要结局
- Percentage of Participants Achieving Complete Cytogenetic Response (CCyR) After Switching to Nilotinib for Participants Not Reporting CCyR at Baseline(Cycles 1, 2, 6, 9, and 12)
- Duration of Complete Cytogenetic Response(18 months of follow up from the first documented response)
- Time to Optimal Imatinib-related Adverse Event Improvement(18 months of follow up from the date of the first dose of study drug to the time to maximum decrease in CTCAE grade of these events)
- Percentage of Participants Achieving Major Molecular Response (MMR) After the Switch in the Therapy for Participants Not Reporting MMR at Baseline(Cycles 1,2,3,6,9,12)
- Log Change in BCR-Abl Transcript Level From Baseline After the Switch Therapy(Cycles 1,2,3,6,9, and 12)
- Time to Major Molecular Response (MMR) in Participants With MMR Absent at Baseline(Cycles 1,2,3,6,9,12)
- Time to Complete Cytogenetic Response in Participants Not Reporting at Baseline(Cycle 12)
- Duration of Major Molecular Response(18 months of follow up from the first documented response)
研究者
研究点 (20)
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