NCT02445742已完成2 期
Single Nucleotide Polymorphism Association With Response and Toxic Effects in Patients With Ph+ CP-CML Treated With Bosutinib After Relapse to Previous Treatment
PETHEMA Foundation13 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 13
- 主要终点
- Safety measured as adverse event gradation
研究概览
简要总结
Prospective, open label, multicenter, phase II study evaluating correlation of SNPs with efficacy and toxicity in patients treated with Bosutinib. A total of 50 patients with previously treated Ph+ chronic phase CML will be included in the study
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent form.
- •Patients with chronic Ph + CML who presented a non-optimal response at 3 months prior to ITK treatment (imatinib, nilotinib, dasatinib). It is defined as a non-optimal response:
- •BCR-ABL> 10% per qRT-PCR (IS) at 3 months of initiation of treatment. BCR / ABL ≥ 1% per qRT-PCR (IS) at 6 months of initiation of treatment. BCR / ABL> 0.1% qRT-PCR (IS) at 12 months of initiation of treatment. BCR-ABL1> 0.1% qRT-PCR (IS) at any time after 12 months of treatment initiation.
- •ECOG Performance Status of 0 or
- •Recovery at Grade 0-1, or at the baseline value of any pretreatment toxicity, except for alopecia. Cases with significant toxicity will be analyzed individually by the study coordinators
- •Able to take daily oral capsules
- •Adequate bone marrow function:
- •Absolute neutrophil count > 1000/mm3 (>1000 x109/L)
- •Platelets ≥ 100,000/mm3 (>100 x109/L)
- •absent any platelet transfusions during the preceding 14 days.
- •Adequate hepatic, and renal function:
- •AST/ALT ≤ 2.5 × upper limit of normal (ULN) or ≤ 5 × ULN if attributable to liver involvement of leukemia
- •Total bilirubin ≤ 1.5 × ULN
- •Creatinine ≤ 1.5 × ULN
- •Age > 18 years
- •Willingness of male and female subjects, who are not surgically sterile or postmenopausal, to use reliable methods of birth control (oral contraceptives, intrauterine devices, or barrier methods used with a spermicide) for the duration of the study and for 30 days after the last dose of Bosutinib.
- •Exclusion Criteria
- •Subjects with Philadelphia chromosome and bcr-abl negative CML.
- •Overt leptomeningeal leukemia. Subjects must be free of CNS involvement for a minimum of 2 months. Subjects with symptoms of CNS involvement must have a diagnostic lumbar puncture prior to study enrollment.
- •Subjects with extramedullary disease only.
- •Prior stem cell transplantation.
- •Major surgery within 14 days or radiotherapy within 7 days before the first dose of Bosutinib (recovery from any previous surgery should be complete before day 1)
- •A history of a clinically significant ventricular arrhythmia, congenital or acquired prolonged QT interval, a baseline QTcF > 0.47 sec (average of triplicate readings) or unexplained syncope, uncontrolled or symptomatic congestive heart failure (CHF) within 3 months, or myocardial infarction (MI) within 6 months.
- •Concomitant use of or need for medications known to prolong the QT interval
- •Uncorrected hypomagnesemia or hypokalemia due to potential effects on the QT interval
- •Recent (within 30 days of study entry) or ongoing clinically significant gastrointestinal disorder (e.g., malabsorption, short bowel syndrome, bleeding, or grade >1 diarrhea, nausea or emesis lasting more than 2 days, despite adequate medical therapy)
- •Pregnant or breastfeeding women
- •Evidence of serious active infection, or significant medical or psychiatric illness
- •Known seropositivity to HIV, or current acute or chronic Hepatitis B or Hepatitis C (antigen positive), cirrhosis, hypokalemia (any grade), or clinically significant abnormal laboratory finding that would, in the investigator's judgment, make the subject inappropriate for this study.
排除标准
- 未提供
研究组 & 干预措施
Bosutinib
Experimental
500 mg/day of Bosutinib during the study until disease progression, unacceptable toxicity, or withdrawal of consent occurs
干预措施: Bosutinib (Drug)
结局指标
主要结局
Safety measured as adverse event gradation
时间窗: 2 years
Safety measured as graded adverse events described on common terminology criteria for adverse events
次要结局
- Efficacy measured as response rate(2 years)
研究者
研究点 (13)
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