EUCTR2013-004323-37-ES进行中（未招募）不适用
Single nucleotide polymorphism association with response and toxic effects in patients with Ph+ CP-CML treated with bosutinib after relapse or intolerance to previous treatment. - BOSTRO
Fundación PETHEMA para el tratamiento de la leucemia y el linfoma0 个研究点目标入组 50 人开始时间: 2015年2月9日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Signed and dated informed consent form.
- •2.Patients with chronic phase of Ph+ CML who showed failure to previous TKI treatment. Failure is defined as BCR-ABL >10% by qRT-PCR (IS) at 3 months of treatment initiation.
- •3.ECOG Performance Status of 0 or 1.
- •4.Recovered to Grade 0-1, or to baseline, from any toxicities of prior treatment, other than alopecia
- •5.Able to take daily oral capsules
- •6.Adequate bone marrow function: a. Absolute neutrophil count > 1000/mm3 (>1000 x109/L) b. Platelets ? 100,000/mm3 (>100 x109/L) absent any platelet transfusions during the preceding 14 days.
- •7.Adequate hepatic, and renal function:
- •oAST/ALT ? 2.5 × upper limit of normal (ULN) or ? 5 × ULN if attributable to liver involvement of leukemia
- •oTotal bilirubin ? 1.5 × ULN
- •oCreatinine ? 1.5 × ULN
- •8.Age > 18 years
- •9.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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1.Subjects with Philadelphia chromosome and bcr-abl negative CML.
- •2. 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.
- •3.Subjects with extramedullary disease only.
- •4.Prior stem cell transplantation.
- •5.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)
- •6.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.
- •7.Concomitant use of or need for medications known to prolong the QT interval
- •8.Uncorrected hypomagnesemia or hypokalemia due to potential effects on the QT interval
- •9.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)
- •10.Pregnant or breastfeeding women
- •11.Evidence of serious active infection, or significant medical or psychiatric illness
- •12.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.
研究者
相似试验
招募中
不适用
A study on the characteristics of Korean female scalp and hairKCT0003508Seoul National University Hospital400
招募中
不适用
A study to determine whether the renalase gene is associated with chronic kidney disease.CTRI/2014/09/004964The Madras Medical Mission1,000
招募中
不适用
To assess association of genetic markers in the MMP genes with hypertensioCTRI/2014/12/005241The Madras Medical Mission Hospital
招募中
不适用
To assess association of genetic markers in the renalase gene with hypertension.CTRI/2017/07/009144The Madras Medical Mission Hospital
招募中
Unknown
Association of variantion of a gene responsible for transporting uric acid with early onset pre-eclampsia in Indian populatioCTRI/2024/06/068602Maulana Azad Medical College