NL-OMON55064招募中2 期
A Phase Ib study of Vyxeos® (liposomal daunorubicin and cytarabine) in combination with Clofarabine in children with relapsed/refractory AML, ITCC-092 - Vyxeos® with Clofarabine for pediatric AM
Prinses Máxima Centrum voor Kinderoncologie0 个研究点目标入组 5 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 99（—）
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
- •(re-) induction therapy)
- •Early 1st relapse (defined as relapse within one year from initial diagnosis)
- •Any relapse of AML after prior allogeneic HSCT
- •Any relapse of AML with high risk cytogenetic characteristics (as defined in
- •Appendix V)
- •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
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
- •Copper metabolism deficiency, such as Wilson's disease
研究者
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