EUCTR2009-009457-13-NL进行中（未招募）不适用
A Phase I/II study of clofarabine in combination with cytarabine and liposomal daunorubicin in children with relapsed/refractory pediatric AML - CLARA-DNX
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Erasmus MC
- 入组人数
- 28
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
- •2nd relapse of AML
- •refractory AML in 1st relapse (defined as = 20% blasts in the bone marrow after the 1st course of standard re-induction therapy)
- •1st early relapse (relapse within one year from initial diagnosis) of AML
- •= 18 years old at initial diagnosis
- •Lansky play score = 60; or Karnofsky performance status = 60
- •Life expectancy =6 weeks
- •Calculated creatinine clearance = 90 ml/min/1.73m2 as calculated by the Schwartz formula for estimated glomerular filtration rate (GFR) where GFR (ml/min/1.73 m2) = k*Height (cm)/serum creatinine (mg/dl). k is a proportionality constant which varies with age and is a function of urinary creatinine excretion per unit of body size; 0.45 up to 12 months of age; 0.55 children and adolescent girls; and 0.70 adolescent boys.
- •Liver function:
- •Serum bilirubin =1.5 × upper limit of normal (ULN)
- •Aspartate transaminase (AST)/alanine transaminase (ALT) =2.5 × ULN
- •Alkaline phosphatase =2.5 × ULN
- •Able to comply with scheduled follow-up and with management of toxicity.
- •For female patients with childbearing potential, a negative test for pregnancy is to be considered before entry on study
- •Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
- •Written informed consent from patients or from parents or legal guardians for minor patients, according to local law and regulations
- •Patient group specific for dose level 5:
- •Newly diagnosed 1st relapse of AML: only patients with early relapses occurring within 1 year of initial diagnosis are eligible
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 39
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Isolated extramedullary relapse, including isolated CNS-relapse
- •Symptomatic CNS leukemia in case of combined relapse
- •Relapsed/refractory acute promyelocytic leukemia (APL)
- •Relapsed/refractory myeloid leukemia of Down Syndrome (ML DS)
- •Other serious illnesses or medical conditions
- •Evidence of fungal infection by:
- •-Evidence of pulmonary infiltrates suggestive of a fungal infection at HR-CT (within 3 weeks prior to enrollment);
- •-A positive Aspergillus serum test (galactomannan), according to local laboratory practice (within 3 weeks prior to enrollment)
- •Evidence of cardiac dysfunction (shortening fraction below 28%)
- •Pregnant or lactating patients
- •Prior or current history:
- •Use of any anticancer therapy within 2 weeks before study entry. The patient must have recovered from all acute toxicities from any previous therapy (note: hematological toxicities do not need to be considered since the patient has overt leukemia).
- •History of prior veno-occlusive disease (VOD)
- •Hypersensitivity to cytarabine, clofarabine or liposomal daunorubicin
- •Specific for dose level 5:
- •Prior stem-cell transplant in CR1
研究者
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