Treatment-free Remission Accomplished With Dasatinib in Patients With CML
关键词
抽象
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.
日期
| 最后验证: | 10/31/2019 |
| 首次提交: | 09/24/2014 |
| 提交的预估入学人数: | 10/14/2014 |
| 首次发布: | 10/19/2014 |
| 上次提交的更新: | 11/26/2019 |
| 最近更新发布: | 11/28/2019 |
| 实际学习开始日期: | 09/30/2014 |
| 预计主要完成日期: | 09/30/2020 |
| 预计完成日期: | 09/30/2021 |
状况或疾病
干预/治疗
Drug: Dasatinib
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Other: 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. | Drug: Dasatinib |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: 1. Diagnosis of CML 2. Treatment of chronic phase CML treated for a minimum of three years exclusively with imatinib 3. Levels of BCR-ABL by RQ-PCR with ≥ 4.5 log reduction from baseline 4. Provide written informed consent 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 6. Age >18 years. 7. Adequate organ liver and renal functions 8. Normal serum levels (within normal limits) Exclusion Criteria: 1. Prior treatment with a TKI (except for imatinib, hydroxyurea, anagrelide or interferon) 2. Taking any medications or substances known to affect CYP3A4. 3. Concurrent medical condition which may increase the risk of toxicity 4. History of significant bleeding disorder unrelated to cancer 5. Cardiac Symptoms 6. Clinically significant hypokalemia or hypomagnesemia that cannot be corrected prior to dasatinib administration |
结果
主要结果指标
1. Molecular Remission [change from baseline in Molecular Profile at 12 months]
