Phase III Trial Evaluating the Effectiveness of a Dose Adjustment of IM on the Molecular Response in Patients With LMC in Chronic Phase Treated With IM 400 mg / Day for at Least Two Years, Complete Cytogenetic Response for at Least One Year
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Percentage of Patients Presenting a Decline of the BCR-ABL Transcript Rate at 12 Months From Baseline - Randomised Study
研究概览
简要总结
The Imatinib Mesylate at a dose of 400 mg / day is the standard treatment for patients with CML-CP. Recent studies show that the quality of response rate (complete cytogenetic response and major molecular response rate) is dependent on the residual plasma Imatinib.
详细描述
The Imatinib Mesylate at a dose of 400 mg / day is the standard treatment for patients with CML-CP. Recent studies show that the quality of response rate (complete cytogenetic response and major molecular response rate) is dependent on the residual plasma Imatinib. This study aims to evaluate the effectiveness of a strategy for dose adjustment of Imatinib Mesylate based on the measurement of the residual plasma imatinib in patients treated for at least 2 years Imatinib 400 mg / d in complete cytogenetic response for at least 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Patients with CML-CP treated for at least two years by Imatinib Mesylate 400 mg / d,
- •Patients in complete cytogenetic response for at least 1 year
- •Patients with residual disease detectable by quantitative RT-PCR (RQ-PCR)
- •Age ≥ 18 years
- •Signed informed consent,
- •Membership of a social security system
排除标准
- •Patients with CML-CP Philadelphia chromosome negative diagnosis.
- •Patients previously treated with Imatinib Mesylate at doses above 400 mg / day
- •Patient with non-hematologic toxicity of grade III or IV in Imatinib Mesylate 400mg / d
- •Patient with a medical condition endocrine, psychiatric, neurological, renal, hepatic or cardiac progressive uncontrolled by medical treatment
- •Pregnant or breastfeeding women, women of childbearing potential not using a contraceptive method effective
- •Known HIV positive
- •Patients previously treated with another tyrosine kinase inhibitor
- •Patient participating in another interventional clinical trial
- •History of non-compliance to Imatinib Mesylate
研究组 & 干预措施
Imatinib 600 (Randomized trial)
Randomized Cohort: Adapted strategy of dosage of Imatinib Mesylate : 600mg/d po
干预措施: Imatinib Mesylate 600 MG Oral Tablet (Drug)
Imatinib 400 (Randomized trial)
Randomized Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po
干预措施: Imatinib Mesylate 400 MG Oral Tablet (Drug)
Imatinib400 (Cohort)
Parallel Cohort: Standard strategy of dosage of Imatinib Mesylate : 400mg/d po
干预措施: Imatinib Mesylate (Drug)
结局指标
主要结局
Percentage of Patients Presenting a Decline of the BCR-ABL Transcript Rate at 12 Months From Baseline - Randomised Study
时间窗: 12 months
The BCR-ABL transcript rate was analysed by molecular biology by RQ-PCR at study entry, 3 months, 6 months, 9 months and 12 months. Treatment is considered effective at 12 months if: * for patients with an inclusion transcript rate less than 0.1%: the transcript rate at 12 months is less or equal to 0.001% or undetectable. * for patients with an inclusion transcript rate greater than 0.1% : the transcript rate at 12 months is less or equal to 0.1% or undetectable. If BCR-ABL transcript level was unavailable at M12, the treatment was considered ineffective.
次要结局
- Overall Survival(First 12 months)
- Progression-free Survival(First 12 months)
- Rate of Decline of 2-log of the BCR-ABL Transcript Rate at 3 ,6, 9 and 12 Months From Baseline - Randomised Study(3, 6, 9 and 12 months)
- Molecular Response at 3, 6, 9 and 12 Months(3, 6, 9 and 12 months)
- Time to Complete Molecular Response (CMR) and Major Molecular Response (MMR)(From date of randomization until the date of complete molecular response (up to 12 months))
- Rate of BCR-ABL Undetectable(12 first months)
- Time to the First BCR-ABL Undetectable(within 12 months following randomization)