JPRN-jRCT2031210230进行中（未招募）3 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)
Yanai Tomoko0 个研究点目标入组 245 人开始时间: 2021年8月6日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 245
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1.Newly diagnosed Philadelphia chromosome-positive (Ph+) or breakpoint cluster region-Abelson (BCR-ABL1)-positive ALL, as defined by the 2017 national comprehensive cancer network (NCCN) guidelines.
- •2.Eastern Cooperative Oncology Group (ECOG) performance status of <=2.
排除标准
- •1.With a history or current diagnosis of chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML).
- •2.Prior/current treatment with any systemic anticancer therapy (including but not limited to any tyrosine kinase inhibitor [TKI]) and/or radiotherapy for ALL, with the exception of an optional prephase therapy or chemotherapy induction (no more than 1 cycle), which should be discussed with the sponsor's medical monitor/designee.
- •3.Currently taking drugs that are known to have a risk of causing prolonged corrected QT (QTc) or torsades de pointes (TdP) (unless these can be changed to acceptable alternatives or discontinued).
- •4.Taking any medications or herbal supplements that are known to be strong inhibitors or strong inducers of cytochrome P450 (CYP)3A4 within at least 14 days before the first dose of study drug.
- •5.Uncontrolled active serious infection that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
- •6.Major surgery within 28 days before randomization (minor surgical procedures such as catheter placement or BM biopsy are not exclusionary criteria).
- •7.Known human immunodeficiency virus (HIV) seropositivity, known active hepatitis B or C infection.
- •8.History of acute pancreatitis within 1 year of study screening or history of chronic pancreatitis.
- •9.Uncontrolled hypertriglyceridemia (triglycerides >450 milligram per deciliter [mg/dL]).
- •10.Diagnosed and treated for another malignancy within 5 years before randomization or previously diagnosed with another malignancy and have any evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
- •11.History or presence of clinically relevant central nervous system (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.
- •12.Clinical manifestations of CNS or extramedullary involvement with ALL other than lymphadenopathy or hepatosplenomegaly.
- •13.Autoimmune disease with potential CNS involvement.
- •14.Known significant neuropathy of Grade >=2 severity.
- •15.Clinically significant, uncontrolled, or active cardiovascular, cerebrovascular, or peripheral vascular disease, or history of or active venous thrombotic/embolic event (VTE) disease.
- •16.Have a significant bleeding disorder unrelated to ALL.
研究者
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