EUCTR2018-001789-41-FR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), all risk scores, =65 years - TIPI
Centre Léon Bérard0 个研究点目标入组 170 人开始时间: 2019年5月17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
- 170
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
- •I1. Male or female patients aged =18 and =65 years at time of inform consent signature
- •I2. Cytologically confirmed CML, Philadelphia chromosome positive 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...
- •I3. No prior treatment for CML with any tyrosine kinase inhibitor (eg. imatinib, dasatinib, nilotinib or 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 (Appendix 1)
- •I5. Adequate organ functions as defined below according to lab tests performed within 7 days before Day 1...
- •I6. Women of child-bearing potential must have a negative serum pregnancy test within 7 days before study drug start 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 performed. Patient should be able and willing to comply with study visits and procedures as per protocol
- •I9. Patients must be covered by a medical insurance
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
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 (hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption)
- •E4. Patients using, or requiring to use while on the study of any not permitted concomitant médications
- •E5. Patients with a malignancy other than CP-CML within 5 years prior to Day 1 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)
- •E.6 Patients with active B or C hepatitis infection
- •E.7 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, brain stroke, heart stroke or evolutive ischemic cardiopathy, venous thromboembolism or pulmonary embolism; 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
- •E.8 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
研究者
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