NCT01243489已完成4 期
CRESCENDO (Compliance: Role Emerges for Success in CML: Evaluation aND Optimisation): A Prospective, Multi-center, Phase IV Study to Assess the Compliance in Patients With Philadelphia Chromosome-positive (Ph+) and/or BCR-ABL Positive Chronic Myelogenous Leukaemia (CML) Under Long-term Imatinib Therapy
Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH46 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2010年10月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 46
- 主要终点
- Patients compliance
研究概览
简要总结
This study on patient's compliance in clinical workaday life aims to assess and to improve CML treatment in Germany by means of adherence supporting measures and to increase adherence awareness by physicians and patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Adult (> 18 years) CML patients in the chronic phase
- •Medical history of cytogenetically confirmed CML-CP by the presence of the Philadelphia chromosome on bone marrow aspirates (a minimum of 20metaphases is required; FISH cannot be used); Philadelphia chromosome negative but BCR- ABL-positive CML patients can be included
- •ECOG performance status of < 2
- •Imatinib treatment for at least 1 year and showing CCyR or MMR
- •Prior treatment with chemotherapeutics such as hydroxyurea or interferon- alpha is allowed
- •Prior periods of accelerated phases are allowed
- •Negative pregnancy test for female patients of childbearing potential within 7 days before initiation of study drug
- •Ability to understand and willingness to sign a written informed consent document prior to any study related screening procedures
- •Written informed consent, including the consent to be called for interviews by the external, neutral institution.
排除标准
- •Patients with prior blast crisis or stem cell transplantation
- •Patients with severe medical condition(s) that in the discretion of the investigator prohibits participation in the study (e.g., clinically significant heart diseases, uncontrolled diabetes, active or uncontrolled infection, impaired gastrointestinal function/diseases)
- •Treatment with drugs or substances, especially those known to modify the cytochrome P450 activity, should be either discontinued or exchanged by different medication (see link for complete list of these medications: http://medicine.iupui.edu/flockhart/table.htm.)
- •Pregnant or breastfeeding women
- •Male or female of childbearing potential unwilling to use contraceptive precautions throughout the trial
结局指标
主要结局
Patients compliance
时间窗: 12 months
To assess patients compliance before and after intervention by comparison of the number of imatinib (Glivec®) tablets taken before and after intervention
次要结局
- Compliance(12 months)
- efficacy of imatinib(12 months)
研究者
研究点 (46)
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