EUCTR2018-000397-30-PL进行中（未招募）1 期
A Phase 3, Randomized, Open-label, Multicenter Study Comparing Ponatinib Versus Imatinib, Administered in Combination With Reduced-Intensity Chemotherapy, in Patients With Newly Diagnosed Philadelphia Chromosome–Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 230
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. Male or female patients aged 18 years or older.
- •2. Newly diagnosed Ph+ or BCR-ABL1 positive ALL, as defined by the 2017 National Comprehensive Cancer Network guidelines.
- •3. Eastern Cooperative Oncology Group (ECOG) performance status of =2.
- •4. Clinical laboratory values as follows, within 30 days before randomization:
- •a) Total serum bilirubin =1.5× the upper limit of normal (ULN), unless due to Gilbert’s syndrome.
- •b) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =2.5× the ULN.
- •c) Serum creatinine =1.5× the ULN and estimated creatinine clearance =30 mL/minute (Cockcroft-Gault formula).
- •d) Serum lipase <1.5× the ULN.
- •5. Normal QT interval corrected per Fredericia method (QTcF) on screening electrocardiogram, defined as QTcF of =450 ms in males or =470 ms in females.
- •6. Female patients who:
- •a) Are postmenopausal for at least 1 year before the screening visit, OR
- •b) Are surgically sterile, OR
- •c) If they are of childbearing potential, agree to practice 1 highly effective method of contraception (such as any form of hormonal contraception, eg, birth control pills or hormonal intra-uterine device [IUD]) and 1 additional effective (barrier) method at the same time, from the time of signing the informed consent through 1 month after the last dose of study drug or a longer period per any local regulation, eg, 35 days for patients in France), OR
- •d) Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient.
- •(Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal,
- •spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)
- •7. Male patients, even if surgically sterilized (ie, status postvasectomy), who:
- •a) Agree to practice effective barrier contraception during the entire study treatment period and through
- •120 days after the last dose of study drug, OR
- •b) Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient. (Periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together.)
- •8. Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
- •9. Willingness and ability to comply with scheduled visits and study procedures.
- •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 196
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 34
排除标准
- •1.Patients with a history or current diagnosis of chronic phase, accelerated phase, or blast phase chronic myeloid leukemia.
- •2.Prior/current treatment with any systemic anticancer therapy (including but not limited to any TKI) and/or radiotherapy for ALL, with the exception of an optional prephase therapy or chemotherapy induction (no more than one cycle), which should be discussed with the sponsor’s medical monitor/designee.
- •3.Treatment with any investigational products within 30 days before randomization or 6 half-lives of the agent, whichever is longer.
- •4.Currently taking drugs that are known to have a risk of causing prolonged QTc or torsades de pointes.
- •5.Taking any medications or herbal supplements that are known to be strong inhibitors or strong inducers of cytochrome P450 3A4 within at least 14 days before the first dose of study drug.
- •6.Uncontrolled active serious infections that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol.
- •7.Major surgery within 28 days before randomization.
- •8.Known seropositive HIV, known active hepatitis B or C infection.
- •9.History of acute pancreatitis within 1 year of study screening or history of chronic pancreatitis.
- •10.Uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL).
- •11.Diagnosed and treated for another malignancy within 5 years before randomization or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have not undergone complete resection.
- •12.History or presence of clinically relevant CNS pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome, or psychosis.
- •13.Clinical manifestations of CNS or extramedullary involvement with ALL other than lymphadenopathy or hepatosplenomegaly.
- •14.Autoimmune disease with potential CNS involvement.
- •15.Known significant neuropathy of Grade =2 severity.
- •16.Clinically significant, uncontrolled, or active cardiovascular, cerebrovascular, or peripheral vascular disease, or history of or active VTE disease, including, but not restricted to:
- •a)Complete left bundle branch block.
- •b)Right bundle branch block plus left anterior hemiblock, or bifascicular block.
- •c)History of or presence of clinically significant ventricular or atrial tachyarrhythmias.
- •d)Clinically significant resting bradycardia (<50 beats per minute).
- •e)Uncontrolled hypertension (HTN; systolic blood pressure [BP] =150 mmHg and/or diastolic BP
- •=90 mmHg). Patients with Stage 2 HTN (systolic BP =140 mmHg and/or diastolic BP =90 mmHg) should be
- •under treatment at study entry per the current AHA guidelines to ensure BP control. Patients requiring 3 or more antihypertensive medications should have controlled HTN for the past 6 months. Isolated elevation(s) of systolic and/or diastolic BP during screening are not exclusionary.
- •f)Any history of myocardial infarction, unstable angina, coronary artery disease, cerebrovascular accident,
- •ischemic stroke or transient ischemic attack. Note: patients with any history of these events, whether
- •considered clinically significant or not, are excluded.
- •g)History of congestive heart failure (NYHA class III or IV) or left ventricular ejection fraction <40%, within 6 months before randomization.
- •h)Symptomatic peripheral
研究者
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