2024-516212-24-00招募中2 期
Frontline Asciminib combination in chronic phase CML
Friedrich-Schiller-Universitaet Jena20 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2024年10月8日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 125
- 试验地点
- 20
- 主要终点
- Rate of MR4 at month 12
研究概览
简要总结
Achievement of deep molecular response (MR4) with the combination of ATP competing BCR‐ABL1 inhibitors with asciminib in newly diagnosed CML patients
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
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)]
- •Serum lipase ≤1.5 x ULN
- •Written informed consent prior to any study procedures being performed
- •Ph‐negative cases or patients with variant translocations who are BCR‐ABL1 positive in multiplex PCR 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
排除标准
- •Allogeneic stem cell transplantation
- •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. (It is required that sexually active men use condom during intercourse while taking the drug and for 2 weeks after stopping treatment and not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid. Female partners of male patients must be advised to use highly effective methods of contraception.)
- •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
- •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 ms on screening ECG o Myocardial infarction within 12 months prior to starting therapy o History of clinically significant/ symptomatic bradycardia o Family history of idiopathic sudden death
- •Patients with resting QTcF ≥450 msec (male) or ≥460 msec (female) at pretreatment, or inability to determine the QTcF interval
- •Patients with uncorrected hypokalemia or hypomagnesemia
- •Other clinically 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)
- •History of acute or chronic pancreatitis
结局指标
主要结局
Rate of MR4 at month 12
Rate of MR4 at month 12
次要结局
未报告次要终点
研究者
Prof. Thomas Ernst
Scientific
Friedrich-Schiller-Universitaet Jena
研究点 (20)
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