EUCTR2008-002288-14-GB进行中（未招募）1 期
Phase I Dose Escalation Study of Clofarabine and Liposomal Daunorubicin in Childhood and Adolescent AML - CLOUD
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
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
入选标准
- •- Diagnosis of acute myelogenous leukaemia (AML).
- •- Patients must be in first relapse within 12 months of initial diagnosis or refractory to induction therapy or be in second or subsequent relapse.
- •- Patients in first or subsequent relapse must have = 5% blasts in the bone marrow, with or without extramedullary disease AND immunophentypic confirmation of AML.
- •- Patients with refractory AML following induction must have > 20% blasts in the bone marrow.
- •- Age must be between 6 months to 18 years old.
- •- Karnofsky or Lansky score of = 50
- •- Patients of childbearing potential must have a negative pregnancy test and agree to use an effective birth control method or evidence of post-menopausal status. Post-menopausal status is defined as either radiation induced oophorectomy with last menses >1 year ago; chemotherapy induced menopause with 1 year interval since last menses.
- •- Normal renal function defined as Serum creatinine based on normal range for age/gender
- •- Normal hepatic function defined as: Total bilirubin NORMAL for age. ALT OR AST < 5 x upper limit of normal (ULN) for age (unless it is known to be related to leukaemic involvement).
- •- Cardiac function defined as: shortening fraction of = 29% by echocardiogram LVEF > 58%
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- First relapse > 1 year from their initial diagnosis of AML
- •- Patients whose previous daunorubicin equivalent exposure equals or exceeds 450mg/m2.
- •- Isolated extramedullary leukemia.
- •- Symptomatic CNS-involvement.
- •- Any evidence of severe or uncontrolled systemic conditions (e.g., systemic infection) or current unstable or uncompensated respiratory or cardiac conditions which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol.
- •- Concurrent treatment or administration of any other experimental drug or with any other anti-cancer therapy.
- •- Patients unable to be regularly followed up for psychological, social, family or geographic reasons.
- •- Patient with expected non-compliance to toxicity management guidelines
研究者
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