Multicentered Phase II Study Evaluating the Activity and Toxicity of Liposomal Cytarabine in the Treatment of Children and Adolescents With Acute Lymphoblastic Leukemia With Resistent or Relapsed Central Nervous System Involvement
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 31
- 试验地点
- 10
- 主要终点
- number of cerebrospinal fluid (CSF) responses
研究概览
简要总结
The purpose of this study is to describe the activity and toxicity of a new formulation of cytarabine called liposomal cytarabine given into the central nervous system for the treatment of central nervous system localization of acute lymphoblastic leukemia (ALL) in children and adolescents.
详细描述
Liposomal cytarabine (DepoCyte) is a new formulation of the drug cytarabine, a drug commonly used in the treatment of ALL. This formulation of the drug can be given intrathecally (into the spinal fluid), and is released slowly over a longer period, about two weeks. This allows a longer exposure of the drug to the central nervous system, and requires fewer intrathecal injections for the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age < 18 years
- •Diagnosis of acute lymphoblastic leukemia (ALL)
- •Central nervous system involvement with malignant cells present in cerebrospinal fluid
- •CNS involvement may be refractive to prior systemic therapy, a first recurrence after prior systemic and intrathecal therapy or a second recurrence
- •CNS involvement may be an isolated lesion or present with other sites of disease
- •ECOG performance status 0-2
- •Life expectancy of at least 8 weeks
- •Absence of severe organ dysfunction
- •Informed consent
排除标准
- •Eligibility for AIEOP studies of first recurrence of ALL,and receiving therapy in a center participating in the AIEOP studies
- •Concurrent treatment with experimental therapies
- •Severe neurologic toxicities from previous chemotherapy
- •Severe coagulopathy at time of recurrence
- •Intrathecal therapy within 1 week of planned study therapy
- •Total body or head and spine radiation within 8 weeks of enrolment
- •Bone marrow transplant within 8 weeks of start of study therapy.
研究组 & 干预措施
Intrathecal liposomal cytarabine
干预措施: liposomal cytarabine (Drug)
结局指标
主要结局
number of cerebrospinal fluid (CSF) responses
时间窗: from two weeks after date of patient registration until the date of second consecutive cerebrospinal fluid exam that is negative for malignant cells, up to 12 weeks
number of patients with grade 3 or higher neurological adverse events, excluding headache) according to CTCAE 4.02
时间窗: assessed from date of patient registration to date of cerebrospinal fluid response, up to 12 weeks
次要结局
- time from patient registration to progression of disease in non CNS site(up to one year)
- concentration of study drug present in CSF at each induction therapy(prior to each induction therapy at 15 day intervals for up to 6 cycles)
- duration of CSF response(up to 12 months)
- worst grade non neurologic Adverse event during induction, according to CTCAE 4.02(up to 12 weeks)
- time to reaching CSF response(date of patient registration to date of CSF response, up to 12 weeks)
- worst grade toxicity after induction therapy according to CTCAE 4.02(up to 12 months)
- overall survival(one year)
- correlation of activity and toxicity with residual study drug level in CSF during induction(measured at 15 day intervals for up to 6 cycles)