EUCTR2015-005248-33-IT进行中（未招募）1 期
Sustained treatment-free remission in BCR-ABL+ chronic myeloid leukemia: a prospective study comparing Nilotinib versus Imatinib with switch to Nilotinib in absence of optimal response. - NA
FONDAZIONE GIMEMA (GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL' ADULTO) FRANCO MANDELLI ONLUS0 个研究点目标入组 600 人开始时间: 2021年6月15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
- 600
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
- •Patients eligible for inclusion in this study have to meet all of the following criteria:
- •Patients with a confirmed diagnosis of BCR/ABL+ CML in chronic phase
- •oDocumented chronic phase CML must meet all the following criteria:
- •¿< 15% blasts in peripheral blood
- •¿< 30% blasts plus promyelocytes in peripheral blood
- •¿< 20% basophils in the peripheral blood
- •¿= 100 x 109/L (= 100,000/mm3) platelets
- •ECOG performance status of 0-2
- •Evidence of typical BCR-ABL transcripts which are amenable to standardized RQ-PCR
- •Adequate end organ function as defined by:
- •oTotal bilirubin < 1.5 x ULN (ULN = upper limit of normal in a local institution lab).
- •Does not apply to patients with isolated hyperbilirubinemia (e.g., Gilbert’s disease) grade < 3
- •oSGOT (AST) and SGPT (ALT) = 3 x ULN
- •oSerum amylase and lipase = 2 x ULN
- •oAlkaline phosphatase = 2.5 x ULN
- •oSerum creatinine < 1.5 x ULN
- •Written informed consent prior to any 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 350
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 250
排除标准
- •Previous treatment with BCR-ABL inhibitors for more than 30 days.
- •Expression of any atypical BCR-ABL transcripts, instead of the classical P210-encoding type with the e13a2 or the e14a2 junction at screening.
- •Previous anticancer agents (hydroxyurea, anagrelide, interferon) for CML for more than three months.
- •Poorly controlled diabetes mellitus (defined as HbA1c >8%)
- •Prior documented history of coronary heart disease, including myocardial infarction, coronary bypass, coronary stent, and symptomatic angina as defined at page 30 in Exclusion Criteria.
- •Uncontrolled hypertension
- •History of peripheral arterial occlusive disease.
- •History of acute pancreatitis within 12 months of study entry, or a past medical history of chronic pancreatitis.
- •Patients actively receiving therapy with strong CYP3A4 inhibitors and/or inducers which cannot be either discontinued or switched to a different medication prior to starting study drug.
- •Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval and for which cannot be either safely discontinued or switched to a different medication prior to starting study drug.
- •Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.
- •Patients unable to understand and to comply with study instructions and requirements.
- •Refusal to give informed consent.
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