Modification of Imatinib to Other Tyrosine Kinase Inhibitors Dependent on 3-months Molecular Response of CML Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Rate of complete cytogenetic response
研究概览
简要总结
The investigators will check the feasibility of using early molecular response for making treatment decisions. Patients diagnosed with chronic myeloid leukemia will commence imatinib treatment. After 3 months of treatment their response will be assessed. If molecular response would be less the 10% (BCR-ABL1/ABL ISI >10%)imatinib therapy will be stopped and patients will start a different TKI (as nilotinib, dasatinib). The investigators will follow on lab and clinical outcomes.
详细描述
Objectives:
To establish a national protocol for the treatment of patients with CML. Patients will be stratified by molecular response, and treatment will be adjusted accordingly.
Secondary outcomes To compare clinical outcomes of patients at high risk (transcript level above 10%) to those at low risk (<10%) while using the early switch approach To evaluate the prognostic value of EUTOS, HASFORD, and SOKAL scores using the early switch strategy Patients Patients may be enrolled to the protocol prior to any TKI treatment or at any time point from commencement of imatinib (started at 400 mg daily) and prior to 3 months assessment, if all the necessary baseline data is available, and all other inclusion criteria are met (patients will be excluded if they received treatment with a tyrosine kinase inhibitor other than imatinib)
Inclusion criteria:
- Adult patients within 6 months after the diagnosis of Philadelphia chromosome-positive CML in the chronic phase
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients within 6 months after the diagnosis of Philadelphia chromosome-positive CML in the chronic phase
- •who were not previously treated (with the exception of hydroyurea) for CML or
- •who were treated with imatinib for CML for up to 3 months, and prior to 3 months assessment (patients will be excluded if they received treatment with a tyrosine kinase inhibitor other than imatinib).
- •Age > 18 years Diagnosis of CML will be made by conventional cytogenetic (chromosome banding analysis) and/or interphase fluorescent in situ hybridization (FISH) analysis of bone marrow containing at least one Philadelphia chromosome-positive metaphase cell. If BCR-ABL1 fusion gene (Philadelphia chromosome) is not detected by conventional cytogenetic analysis, the diagnosis of CML can be confirmed based on FISH analysis or molecular analysis (demonstration of bcr-abl by polymerase chain reaction (PCR)).
- •Inclusion of patients with any organ dysfunction (cardiac, renal, respiratory, liver) can be done based on the decision of the treating physician.
排除标准
- •Patients will be excluded if they received treatment with a tyrosine kinase inhibitor other than imatinib (i.e., nilotinib, dasatinib) before study entry. Patients may take hydroxyurea or anagrelide for up to 4 weeks prior to imatinib treatment.
结局指标
主要结局
Rate of complete cytogenetic response
时间窗: 12 months
次要结局
- PFS(12 months)
- Overall survival(12 months)
- Rate of major molecular response(12, 24 months)
- Severe Adverse events(12 months)
研究者
LIAT VIDAL FISHER
Dr.
Rabin Medical Center