NCT01239485Unknown1 期
Phase I Study of IRNEA (Irinotecan, Etoposide, Cytarabine) for Refractory or Relapsed Acute Leukemia in Children and Adolescents
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- To determine the maximum tolerable dose of irinotecan in combination with etoposide, cytarabine for refractory or relapsed acute leukemia in pediatric patient.
研究概览
简要总结
The purpose of this study is to determine the maximum tolerable dose of irinotecan in combination with etoposide, cytarabine for refractory or relapsed acute leukemia in pediatric 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
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ALL or AML.
- •Prior therapy Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
- •ALL patients must have had two or more prior therapeutic attempts defined as
- •Persistent (BM blast>5%) initial disease after two induction attempts, or
- •Persistent (BM blast>5%) after re-induction attempt for first relapse or
- •Relapse after one re-induction attempt (2nd relapse)
- •AML patients must have one or more prior therapeutic attempts defined as
- •Refractory (BM blast>20%) initial disease after one induction attempts, or
- •Persistent (BM blast>5%) initial disease after two induction attempts, or
- •Relapse after one induction attempt (1st relapse)
- •Relapse after stem cell transplant: Patients are eligible 12 weeks after allogeneic stem cell transplant as long as patients are not actively being treated for GvHD and have recovered from transplant-related toxicities. Patients are eligible 8 weeks from the day of stem cell infusion for myeloablative autologous stem cell transplant, if hematological and all other eligibility criteria are met.
- •Age: ≤ 21 years.
- •Performance status: ECOG 0-
- •Patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases.
- •Heart: a shortening fraction ≥ 28%
- •Liver: total bilirubin < 2 × upper limit of normal; ALT < 3 × upper limit of normal.
- •Kidney: creatinine <2 × normal or a creatinine clearance (GFR) > 60 ml/min/1.73m
- •Patients must lack any active viral infections or active fungal infection.
- •Patients (or one of parents if patients age < 19) should sign informed
排除标准
- •Pregnant or nursing women.
- •Malignant (except acute leukemia) or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy.
- •Psychiatric disorder that would preclude compliance.
- •Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
研究组 & 干预措施
Irinotecan
Experimental
干预措施: Irinotecan (Drug)
结局指标
主要结局
To determine the maximum tolerable dose of irinotecan in combination with etoposide, cytarabine for refractory or relapsed acute leukemia in pediatric patient.
时间窗: 28 days
次要结局
- To evaluate the incidence and severity of toxicity and treatment related mortality. 2. To evaluate the response rate. 3. To determine the pharmacokinetic profile of irinotecan in combination with etoposide, cytarabine in pediatric patients.(2 years)
研究者
研究点 (1)
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