EUCTR2018-002256-33-DE进行中（未招募）1 期
Frontline Asciminib combination in chronic phase CML - FASCINATIO
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
- 155
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
- •Male or female patients with diagnosis of CP-CML with cytogenetic confirmation of the Ph+ chromosome [t(9;22)(q34;q11)].
- •Ph-negative cases or patients with variant translocations who are BCR-ABL1 positive in multiplex PCR 35 will be also considered eligible.
- •ECOG performance status of =2.
- •Age = 18 years old (no upper age limit is given)
- •Serum levels of potassium, magnesium, total calcium within the normal limits (=LLN [lower limit of normal] and =ULN [upper limit of normal]). Correction of electrolytes levels with supplements to fulfil enrolment criteria is allowed.
- •AST and ALT =2.5 x ULN or 5.0 x ULN if considered due to leukemia
- •Alkaline phosphatase =2.5 x ULN unless considered due to leukemia
- •Total bilirubin =1.5 x ULN, except known Gilbert disease
- •Serum creatinine =2 x ULN
- •Written informed consent prior to any study procedures being performed
- •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 78
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 77
排除标准
- •Allogeneic stem cell transplantation
- •Known impaired cardiac function, including any of the following:
- •o Congenital long QT syndrome
- •o History of or presence of clinically significant ventricular or atrial tachyarrhythmia
- •o QTc >450 msec on screening ECG
- •o Myocardial infarction within 12 months prior to starting therapy
- •Other clinical significant heart disease (e.g. unstable angina, congestive heart failure)
- •Acute or chronic viral hepatitis with moderate or severe hepatic impairment (Child-Pugh scores >6), even if controlled
- •Other concurrent uncontrolled medical conditions (e.g., active or uncontrolled infections, acute or chronic liver and renal disease) that could cause unacceptable safety risks or compromise compliance with the protocol
- •Impaired gastrointestinal function or disease that may alter the absorption of study drug (e.g., ulcerative disease, uncontrolled nausea, vomiting and diarrhea, malabsorption syndrome, small bowel resection or gastric by-pass surgery)
- •Concomitant medications known to be strong inducers or inhibitors of the CYP450 isoenzyme CYP3A4
- •Patients who have undergone major surgery =2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
- •Patients who are pregnant or breastfeeding or women of reproductive potential not employing an effective method of birth control. Women of childbearing potential must have a negative serum pregnancy test within 14 days of study start. Post-menopausal women must be amenorrheic for at least 12 months in order to be considered of non-childbearing potential. Male and female patients must agree to employ an effective method of birth control throughout the study and for up to 2 weeks following discontinuation of study drug
- •Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory)
- •Known serious hypersensitivity reactions to asciminib, imatinib, nilotinib or dasatinib
- •Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention
- •Patients unwilling or unable to comply with the protocol.
研究者
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