EUCTR2020-003912-28-IT进行中（未招募）1 期
Ponatinib for the management of minimal residual disease (MRD) and hematologic relapse in adult Ph+ acute lymphoblastic leukemia (Ph+ ALL) patients. - ALL2620
FONDAZIONE GIMEMA (GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL' ADULTO) FRANCO MANDELLI ONLUS0 个研究点目标入组 67 人开始时间: 2021年6月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 67
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. Ph+ ALL patients with evidence of MRD disease or in hematologic and extra-hematologic relapse/refractoriness after any previous treatment, will be considered eligible to enter the study.
- •2. Age =18 years old with no upper age limit.
- •3. Adequate hepatic function as defined by the following criteria:
- •- total serum bilirubin =1.5 x upper limit of normal (ULN), unless due to Gilbert’s syndrome
- •- alanine aminotransferase (ALT) =2.5 × ULN
- •- aspartate aminotransferase (AST) =2.5 × ULN.
- •4. Adequate pancreatic function as defined by the following criterion: - serum lipase and amylase =1.5 × ULN.
- •5. For females of childbearing potential, a negative pregnancy test must be documented prior to enrollment.
- •6. Female and male patients who are fertile must agree to use an effective form of contraception with their sexual partners from enrollment through 4 months after the end of treatment.
- •7. Signed written informed consent according to ICH/EU/GCP and national local laws.
- •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 33
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 34
排除标准
- •1. WHO performance status = 50% (Karnofsky) or = 3 (ECOG).
- •2. Uncontrolled active HBV or HCV hepatitis, or AST/ALT = 2.5 x ULN and bilirubine = 1.5 x ULN not due to the disease.
- •3. History of acute pancreatitis within 1 year of study or history of chronic pancreatitis.
- •4. History of alcohol abuse.
- •5. Ongoing or active uncontrolled infections.
- •6. Uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL).
- •7. Clinically significant, uncontrolled or active cardiovascular disease, specifically including, but not restricted to:
- •- any history of myocardial infarction, stroke, or revascularization
- •- unstable angina or transient ischemic attack within 6 months prior to enrollment
- •- congestive heart failure within 6 months prior to enrollment, or left ventricular ejection fraction (LVEF) less than lower limit of normal per local institutional standards within 6 months prior to enrollment
- •- history of clinically significant (as determined by the treating physician) atrial arrhythmia
- •- any history of ventricular arrhythmia
- •- any history of venous thromboembolism including deep venous thrombosis or pulmonary embolism
- •- uncontrolled hypertension (diastolic blood pressure >90 mm Hg; systolic >140 mm Hg). Patients with hypertension should be under treatment on study entry to effect blood pressure control.
- •8. Taking medications that are known to be associated with Torsades de Pointes.
- •9. Taking any medications or herbal supplements that are known to be strong inhibitors of CYP3A4 within at least 14 days before the first dose of ponatinib.
- •10. Creatinine level >2.5mg/dl or glomerular filtration rate (GFR) <20 ml/min or proteinuria >3.5 g/day.
- •11. Patients who are currently receiving treatment with any of the medications listed in Appendix E if the medications cannot be either discontinued or switched to a different medication prior to starting study drug. The medications listed in Appendix E have the potential to prolong QT.
研究者
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