CTIS2023-510264-12-00进行中（未招募）1 期
Trial Of Imatinib After Ponatinib Induction (Tipi) - A multicentre, open label phase II trial evaluating the safety and efficacy of ponatinib induction followed by imatinib maintenance in adult patients with Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) = 65 years - ET18000120
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 170
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
- 18 至 64（—）
- 性别
- All
入选标准
- •I1.Male or female patients aged =18 and =65 years at time of inform consent signature., I2.Cytologically confirmed CML, Philadelphia chromosome positive (Ph+) with or without additional chromosomal abnormalities and/or BCR-ABL positive (Major BCR (M-BCR) transcript exclusively), i. e. Cryptic Philadelphia chromosome patients can be enrolled: *diagnosed within the past 3 months prior to D1 (i.e. within 90 days [± 7 days] since the date of first cytogenetic analysis), *in chronic phase defined by i) <15 % blasts in peripheral blood and bone marrow, ii) <30 % blasts plus promyelocytes in peripheral blood and bone marrow; iii) <20 % basophils in peripheral blood and iv) =100 X 109 platelets/L in peripheral blood, *no extra-medullary disease. *all EUTOS long-term survival Scores, I3.No prior treatment for CML with any tyrosine kinase inhibitor (eg. imatinib, dasatinib, nilotinib, bosutinib), or busulphan, interferon-alpha, homoharringtonine, cytosine arabinoside, or any other investigational agent; with the exception of hydroxyurea and/or anagrelide which are the only authorized prior treatments., I4.Eastern Cooperative Oncology Group performance status (ECOG PS) of 0, 1 or 2., I5. Adequate organ functions as defined below according to lab tests performed within 7 days before Day 1: *Renal function: oSerum creatinine clearance = 50 mL/min/1.73m2 according to CKD-EPI formula or serum creatinine = 2 upper limit of normal (ULN) (Appendix 2). *Hepatic function: oSerum bilirubin < 1.5 × ULN, with the following exception: Patients with known Gilbert disease who have serum bilirubin level = 3 ULN may be enrolled. oAspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase = 2.5 ULN. oAmylase or Lipase = 1.5 × ULN. *Total cholesterol =1.5 ULN., I6.Women of child-bearing potential must have a negative serum pregnancy test within 7 days before D1 and must agree to use an effective form of contraception from the time of the negative pregnancy test up to 3 months after the last dose of study treatments., I7.Fertile men must agree to use an effective method of contraception during the study and for up to 3 months after the last dose of study treatments., I8.Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures and should be willing to comply with study visits and procedures required per protocol., I9.Patients must be covered by a medical insurance.
排除标准
- •E1.Any form of prior auto- or allo-hemopoietic stem cell transplant., E2.Hypersensitivity to the active substance or to any of the excipients of ponatinib and imatinib (see respective IB/SmPC)., E3.Inability to take oral medication including malabsorption syndrome or other illness that could affect oral absorption of the study treatments (any hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption)., E4.Patients using, or requiring to use while on the study any not permitted concomitant medications including: *Any approved or not anti-cancer systemic treatment including chemotherapy, targeted therapy, immunotherapy or any biological therapy, *Any investigational agents, *Any treatment able to induce « torsades de pointes », *Any strong inducers and inhibitors of CYP3A4., E5.Patients with a malignancy other than CP-CML within 5 years prior to D1 with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated in situ carcinoma of the cervix, basal or squamous cell skin cancer, localised prostate cancer or ductal in situ carcinoma treated surgically with curative intent)., E6. Patients with active B or C hepatitis infection., E7. Patients with significant cardiovascular disease, such as New York Heart Association cardiac disease Class II or greater, myocardial infarction within 3 months prior to D1, unstable arrhythmias, unstable angina, peripheral arterial occlusive disease, venous thromboembolism or pulmonary embolism, brain stroke, or evolutive ischemic cardiopathy,; prolonged corrected QT interval (QTc) interval on baseline electrocardiogram (>450 msec on the Fridericia’s correction) despite correction of predisposants factors; long congenital QT syndrome., E8. Any of the following medical conditions despite adequate therapeutic management: *Uncontrolled HTA despite adequate ongoing treatment. * Diabetes with documented target organ damage., E9.Pregnant or lactating women.
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