EUCTR2018-000397-30-IT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) - An Efficacy Study Comparing Ponatinib Versus Imatinib, Administered in Combination With Reduced-Inte
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 320
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. Molecular assessment of BCR-ABL1 must demonstrate the presence of a p190 (ie, e1a2) or p210 (ie, e13a2 or
- •e14a2 [also known as b2a2 or b3a2]) transcript type.
- •4. Eastern Cooperative Oncology Group performance status of =2.
- •5. Clinical laboratory values as follows, within 30 days before randomization:
- •a) Total serum bilirubin =1.5× the upper limit of normal (ULN).
- •b) Alanine aminotransferase or aspartate aminotransferase =2.5× the ULN.
- •c) Serum creatinine =1.5× the ULN and estimated creatinine clearance =40 mL/minute (Cockcroft-Gault formula).
- •d) Serum lipase and amylase <1.5× the ULN.
- •6. Normal QT interval corrected per Fridericia method (QTcF) on screening electrocardiogram, defined as QTcF of
- •=450 ms in males or =470 ms in females.
- •7. 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 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
- •d) Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject.
- •(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. 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 subject.
- •(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.)
- •9. 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.
- •10. 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 272
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 48
排除标准
- •1. Patients with a history or current diagnosis of chronic phase, accelerated phase, or blast phase chronic myeloid
- •2. Prior/current treatment with any systemic anticancer therapy (including but not limited to any TKI) and/or
- •radiotherapy for cancer, with the exception of an optional prephase therapy, 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 (unless these can be changed to acceptable alternatives or discontinued) (Appendix E).
- •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. Active serious infection requiring antibiotics within 14 days before the first dose of study drug.
- •7. Major surgery within 28 days before randomization (minor surgical procedures such as catheter placement or BM biopsy are not exclusionary criteria).
- •8. Ongoing or active systemic infection, known seropositive HIV, or 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. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are 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. Active ALL in the CNS (confirmed by cerebrospinal fluid analysis).
- •14. Autoimmune disease with potential CNS involvement.
- •15. Known significant neuropathy of Grade =2 severity.
研究者
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