NCT00930098已完成2 期
A Phase II, Open-Label Study of Clofarabine in Paediatric Patients With Refractory/Relapsed Acute Lymphoblastic Leukaemia
Genzyme, a Sanofi Company36 个研究点 分布在 6 个国家目标入组 74 人开始时间: 2003年12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
- 74
- 试验地点
- 36
- 主要终点
- Overall response rate after 1 course or more
研究概览
简要总结
This study is for a population of patients with few or no alternative options that was conducted to determine the response rate to clofarabine. Additionally the study will provide information on the safety profile, impact of overall survival, and impact on remission duration with clofarabine. It is a single arm study and has no comparator.
详细描述
Note: This clinical trial was conducted by Bioenvision Ltd. Bioenvision Ltd. was acquired by Genzyme Corporation Oct 2007.
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
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of ALL and confirmed by pathologic assessment.
- •Be ≤ 21 years old at time of initial diagnosis.
- •Eligible patients must have: Primary refractory disease; OR relapsed or refractory disease after a minimum of 2 prior blocks of treatment.
- •Must not be eligible for therapy of higher curative potential.
- •Have a Karnofsky Performance Status of ≥ 50 or Lansky Performance Scale of ≥
- •Provide a signed, written informed consent from parent or guardian or young adult patients.
- •Be able to comply with study procedures and follow-up examinations.
- •Have adequate cardiac function without treatment.
- •Have adequate organ function as indicated by the laboratory values for serum creatinine, serum bilirubin, AST and ALT, obtained within 7 days prior to registration.
排除标准
- •Received previous treatment with clofarabine.
- •Patients with isolated extramedullary disease.
- •Have received prior BMT or PBSCT within the last 6 months.
- •Have received prior BMT or PBSCT more than 6 months ago, but now has compromised organ function.
- •Have an active, uncontrolled systemic infection.
- •Are pregnant or lactating. Male and female patients who are fertile must agree to use an effective means of birth control to avoid pregnancy.
- •Have a psychiatric disorder that would interfere with consent, study participation, or follow-up.
- •Have received any other chemotherapy within the previous 2 weeks and must have recovered from acute toxicity oa all previous therapy prior to enrollment.
- •Have any other severe concurrent disease.
- •Have recent history of significant renal, hepatic or pulmonary dysfunction, or cardiac dysfunction or on treatment to support cardiac function.
- •Have CNS disease.
结局指标
主要结局
Overall response rate after 1 course or more
时间窗: minimum of 1 course and maximum of 12 courses
次要结局
- Rate of response (complete, complete with incomplete blood count recovery, partial) after 1 course or more(minimum of 1 course and maximum of 12 courses)
- Overall response rate after 2 courses or more(minimum of 2 courses and maximum of 12 courses)
- Time-to-event parameters including duration of remission and overall survival(Until death of patient or until end of study treatment for last enrolled patient)
- Safety and tolerability(Until death of patient or until end of study treatment for last enrolled patient)
- Number of patients received bone marrow or peripheral blood stem cell transplantation and the time to transplant following commencement of Clofarabine(Until death of patient or until end of study treatment for last enrolled patient)
- Determine pharmacokinetic profile and intracellular triphosphate and levels of clofarabine(every day during the first course of treatment)
- Document the metabolic pathways that may predict Clofarabine sensitivity or resistance(day 1, day 5, day 6 and day 7 of the first course)
研究者
研究点 (36)
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