NCT02975115Unknown不适用
The Catholic University of Korea Cancer Research Institute
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 102
- 主要终点
- Rate of CMR(complete molecular response)
研究概览
简要总结
This study is designed to confirm the efficacy of dasatinib 100mg once daily in producing a complete molecular response and to prove a possibility of "Operational Cure" in CMR patients.
详细描述
This study also examines kinetics of complete molecular responses using new highly sensitive PCR based technology, digital PCR, which is reported to have a sensitivity down to 6 log reduction.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
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
- •Patients must have Ph+ CML in CP
- •newly diagnosed chronic phase CML, except hydroxyurea, anagrelide and within 7 days imatinib treatment
- •Subjects must be enrolled in this study within approximately 3 months (90 days) after the date of first being diagnosed with CML. Subjects are allowed to have clonal chromosomal abnormalities in addition to the Philadelphia chromosome and remain eligible
- •0-2 ECOG Performance Status (PS) Score
- •Adequate hepatic function test
- •Adequate renal function test
- •Adequate other organ functions
- •Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy
- •WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of investigational product.
- •Subjects agree to sign informed consent
排除标准
- •WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least one month (4 weeks) before and for at least 1 month (4 weeks) after the last dose of study medication.
- •WOCBP using a prohibited contraceptive method (Not applicable for this study).
- •Women who are pregnant or breastfeeding.
- •Women with a positive pregnancy test at enrollment or prior to administration of study medication.
- •Men whose sexual partners are WOCBP, who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least one month (4 weeks) after completion of study medication.
- •A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy.
- •Known pleural effusion at baseline.
- •Uncontrolled or significant cardiovascular disease
- •History of significant bleeding disorder unrelated to CML
- •Prior chemotherapy for peripheral stem cell mobilization. (Prior collection of un-mobilized peripheral blood stem cells is permitted).
- •Prior or concurrent malignancy
- •Evidence of digestive dysfunction that would prevent administration of study therapy by mouth
- •Uncontrolled diabetes
结局指标
主要结局
Rate of CMR(complete molecular response)
时间窗: 36 month
Level of Bcr-Abl transcript (Conventional Q-RT-PCR)
次要结局
- Rate of MMR(major molecular response)(3,6,12,24 and 36 months)
研究者
Dong-Wook Kim
Director
Seoul St. Mary's Hospital
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