EUCTR2020-000142-34-DK进行中（未招募）1 期
A Phase Ib study of Vyxeos® (liposomal daunorubicin and cytarabine) in combination with Clofarabine in children with relapsed/refractory AML, ITCC-092 - Vyxeos® and Clofarabine in relapsed/refractory pediatric AM
Princess Máxima Center for pediatric oncology0 个研究点目标入组 25 人开始时间: 2021年4月28日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
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
- •Age =1 year and = 21 years
- •Any = 2nd relapse of AML
- •Refractory AML (defined as = 20% blasts in the bone marrow after standard induction therapy)
- •Early 1st relapse (defined as relapse within one year from initial diagnosis) of AML
- •Any relapse of AML with high risk cytogenetic characteristics (as
- •defined in Appendix V)
- •Any relapse of AML after prior allogenic HSCT
- •Complete initial work-up within 7 days prior to study entry, including bone-marrow aspiration, lumbar puncture (without intrathecal therapy)
- •Lansky play score = 60 for patients <16 years of age; or Karnofsky performance status = 60 for patients = 16 years of age (see Appendix I for Performance scales).
- •Life expectancy > 6 weeks
- •The patient must have a calculated GFR = 70mL/min/1.73 m2.
- •Liver function: total serum bilirubin = 3 mg/dl or 50 µmol/L and aspartate transaminase (AST) and alanine transaminase (ALT) =200 U/L
- •Adequate cardiac function (defined as shortening fraction =28% or ejection fraction =50%)
- •For female patients with childbearing potential, a negative test for pregnancy is to be performed before entry on study.
- •Male and female patients must use a highly effective contraceptive method during the study and for a minimum of 6 months after study treatment.
- •Female patients may not breastfeed during the study and for a minimum of 3 months after study treatment.
- •Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule is required; those conditions should be discussed with the patient before registration in the trial.
- •Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
- •Concomitant treatments:
- •Concomitant administration of any other experimental drug under investigation, or concurrent treatment with any other anti-cancer therapy other than specified in the protocol is not allowed.
- •GCSF will not be used for priming and no routine GCSF support is allowed during the 1st course, except for life-threatening infections.
- •Additional criteria:
- •At least 6 patients must be enrolled with an M3 or a WBC count >10x109/L with blasts
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 25
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 3
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Evidence of a currently uncontrolled bacterial, viral or parasitic infection
- •Evidence of a fungal infection, defined as either:
- •- Pulmonary infiltrates suggestive of a fungal infection at HR-CT (within 3 weeks prior to enrollment)
- •- Positive Aspergillus serum test (galactomannan), according to local laboratory practice (within 3 weeks prior to enrollment)
- •Evidence of isolated extramedullary relapse, including isolated CNS-relapse
- •Evidence of CNS3 or symptomatic CNS leukemia
- •Down Syndrome
- •Evidence of relapsed/refractory acute promyelocytic leukemia (APL)
- •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)
- •Known hypersensitivity to cytarabine, clofarabine or liposomal daunorubicin
研究者
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