EUCTR2015-001174-18-Outside-EU/EEA进行中（未招募）不适用
A Phase I/II Dose-Escalation Study of Clofarabine in Combination with Etoposide and Cyclophosphamide in Pediatric Patients with Refractory or Relapsed Acute Leukemias
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •NOTE: the following eligibility criteria were applicable to acute lymphoblastic leukemia (ALL) and acute myelogenous leukemia (AML) patients for the Phase 1 portion of this study, and to ALL patients for the Phase 2 portion of the study (only ALL patients were allowed in the Phase 2 portion of the study).
- •ALL with > 25% blasts in bone marrow; AML with = 5% blasts in bone marrow; ALL and AML patients may have extramedullary disease
- •Karnofsky Performance Status = 50 for patients > 10 years old; Lansky Performance Status = 50 for patients = 10 years old
- •Prior therapy: AML: 1-2 prior induction regimens and = 1 hematopoietic stem cell transplant (HSCT); ALL: 1-3 prior induction regimens
- •Adequate liver, renal, pancreatic, and cardiac function
- •Have received no prior HSCT (study amended in Phase 2 to exclude patients with prior HSCT)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 44
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 6
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •NOTE: the following eligibility criteria were applicable to ALL and AML patients for the Phase 1 portion of this study, and to ALL patients for the Phase 2 portion of the study (only ALL patients were allowed in the Phase 2 portion of the study).
- •Burkitt's leukemia
- •Previous treatment with clofarabine
- •Uncontrolled systemic fungal, bacterial or other infection and 48 hrs negative blood cultures required for patients with a history of fever within 3 days of enrollment
- •Active CNS involvement (i.e., should be CNS1 or CNS2)
- •Inadequate time since last therapy: = 14 days since last cytotoxic chemotherapy; = 7 days since last biologic therapy; = 14 days since last monoclonal antibody therapy
- •Have received prior HSCT (study amended in Phase 2 to exclude patients with prior HSCT)
- •Pregnant or lactating
- •Have tested positive for hepatitis B or hepatitis C infection or history of cirrhosis
研究者
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