Treatment-free Remission Accomplished With Dasatinib in Patients With CML
试验速览
- 阶段
- 2 期
- 入组人数
- 131
- 试验地点
- 12
- 主要终点
- Molecular Remission
研究概览
简要总结
The purpose of this study is to find out how to increase the potential for achieving an "operational cure" from chronic myeloid leukemia. An "operational cure" is a state in which a person does not require further treatment, although there may be some remaining cancer cells. Patients would normally remain on a TK inhibitor indefinitely within a standard of care setting for chronic myeloid leukemia. Within this clinical trial, patients will discontinue their TK inhibitor prematurely. If any signs of progression are identified, dasatinib will be introduced.
This research is being done because dasatinib has been shown to achieve a greater response in a much higher proportion of patients as compared to imatinib. Dasatinib is approximately 300 times more potent than imatinib, and it is possible that a greater response can be achieved by dasatinib than by imatinib.
详细描述
This is an open label, single arm Phase II trial that will examine how safe and effective it will be for patients with chronic myeloid leukemia (CML) to discontinued first line tyrosine kinase inhibitor (TKI) therapy.
The main goal of this study is to determine the potential role of dasatinib (the study drug) in helping patients with CML attain a sustained treatment free remission.
During this study the safety and tolerability of Dasatinib will be evaluated by means of drug related toxicity, adverse event reports, physical examinations and laboratory safety evaluations.
The study period for an individual patient is expected to be approximately between 30-72 months.
A total of 135 patients will be recruited from 10 Canadian centres.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Diagnosis of CML
- •Treatment of chronic phase CML treated for a minimum of three years exclusively with imatinib
- •Levels of BCR-ABL by RQ-PCR with ≥ 4.5 log reduction from baseline
- •Provide written informed consent
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- •Age >18 years.
- •Adequate organ liver and renal functions
- •Normal serum levels (within normal limits)
排除标准
- •Prior treatment with a TKI (except for imatinib, hydroxyurea, anagrelide or interferon)
- •Taking any medications or substances known to affect CYP3A
- •Concurrent medical condition which may increase the risk of toxicity
- •History of significant bleeding disorder unrelated to cancer
- •Cardiac Symptoms
- •Clinically significant hypokalemia or hypomagnesemia that cannot be corrected prior to dasatinib administration
研究组 & 干预措施
Dasatinib
This research is being done because dasatinib has been shown to achieve a deep molecular response in patients as compared to imatinib.
Patients in this study will continue to take their own supply of imatinib for three months to ensure they have achieved a stable response to the drug. Once this has been confirmed, imatinib will be stopped and the patients in this study will then be monitored to see if their CML relapses. This period can last up to 2.5 years.
If the participant has a relapse, they will be started on dasatinib and will continue to receive dasatinib for up to 2 years.
If after one year they achieve a response, they will continue on dasatinib for one more year. If the participant maintains this response, they will have the option of discontinuing dasatinib.
干预措施: Dasatinib (Drug)
结局指标
主要结局
Molecular Remission
时间窗: change from baseline in Molecular Profile at 12 months
次要结局
未报告次要终点