NCT00388531已完成2 期
Multicenter, Prospective, Open Label Trial, Uncontrolled to Determine the Efficacy and Safety of Depocyt ® for the Treatment of CNS Relapse in Adult Patients With Lymphoblastic Leucemia or Very Aggressive Lymphoma
PETHEMA Foundation10 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2006年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 10
- 主要终点
- The primary purpose:
研究概览
简要总结
The first purpose is to confirm or not the efficacy of only one administration of DepoCyte®.
详细描述
It is a clinical study multicenter, prospective, open label trial, uncontrolled and nonrandomized
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Patients with acute lymphoblastic leukemia or very aggressive Non-Hodgkin-Lymphoma (Burkitt/Burkitt-like) and CNS relapse.
- •CNS involvement must be demonstrated by:
- •A positive ventricular or lumbar CSF cytology defined as CSF cell counts > 5/µl (19/3 cells), obtained within 10 days prior to inclusion OR
- •Characteristic signs and symptoms of neoplastic meningitis PLUS an MRI or CT scan indicating the presence of meningeal involvement. Patients with combined relapse in CNS and other locations may be included in case that systemic therapy with CNS active drugs (HDMTX;HDAC, Thiotepa) can be postponed for at least 2 weeks.
- •Karnofsky >60%
- •Age >18 years old
- •Recovery from grade III/IV toxicities attributable to prior treatment with the exception of hematotoxicity.
- •No severe heart, lung, liver or kidney dysfunction.
- •The patient or guardian must be competent to provide informed consent and must provide written informed consent prior to the initiation of study procedures
排除标准
- •Failure (as defined by no clearance of the CSF) to > 1 dose of prior intrathecal MTX or cytarabine or triple (MTX, ARAC, dexamethasone) therapy
- •History of previous severe neurotoxicity (grade III-IV) attributed to intrathecal therapy or systemic high-dose therapy with methotrexate or cytarabine (vincristine induced peripheral neuropathy is accepted)
- •Prior CNS relapse < 1 month before
- •uncontrolled infection
- •The patient must not be pregnant or breast feeding. If the patient is a female of child-bearing potential she must have a negative (urine or serum) pregnancy test and be using effective methods to prevent pregnancy
结局指标
主要结局
The primary purpose:
时间窗: 1 year
response rate after one application of DepoCyte®.
时间窗: 1 year
次要结局
- Death in induction and in CR, Time to neurological progression, The frequency of improvement in pre-existing meningeal-disease related neurological symptoms,Karnofsky Performance Status,Survival,Toxicity according to CTCAE v.3(6 months)
研究者
研究点 (10)
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