EUCTR2009-009457-13-DE进行中（未招募）1 期
A Phase I/II study of clofarabine in combination with cytarabine and liposomal daunorubicin in children with relapsed/refractory pediatric AML - CLARA-DNX
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Erasmus MC
- 入组人数
- 34
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 re-induction therapy according to the AML 2001/01 protocol)
- •1st early relapse (relapse within one year from initial diagnosis) of AML (only when the Relapsed AML 2001/01 study is closed)
- •= 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
- •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
- •Current uncontrolled infection
- •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
研究者
相似试验
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-DNXEUCTR2009-009457-13-ATErasmus MC28
进行中（未招募）
不适用
This study aims to investigate the safety and efficacy of clofarabine, given in combination with cytarabine and liposomal daunorubicin, in the treatment of children with relapsed/refractory acute myeloid leukemia (AML)Relapsed/refractory acute myeloid leukemiaMedDRA version: 14.0Level: LLTClassification code 10066638Term: Acute myeloid leukemia progressionSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.0Level: LLTClassification code 10060558Term: Acute myeloid leukemia recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2009-009457-13-NLErasmus MC28
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-DNXRelapsed/refractory acute myeloid leukemiaMedDRA version: 12.0Level: LLTClassification code 10060558Term: Acute myeloid leukemia recurrentMedDRA version: 12.0Level: LLTClassification code 10066638Term: Acute myeloid leukemia progressionEUCTR2009-009457-13-CZErasmus MC28
进行中（未招募）
1 期
A Phase I/II study of clofarabine in combination with cytarabine and liposomal daunorubicin in children with relapsed/refractory pediatric AML - CLARA-DNXRelapsed/refractory acute myeloid leukemiaMedDRA version: 9.1Level: LLTClassification code 10060558Term: Acute myeloid leukemia recurrentMedDRA version: 9.1Level: LLTClassification code 10066638Term: Acute myeloid leukemia progressionEUCTR2009-009457-13-FRHospices Civils de Lyon34
进行中（未招募）
不适用
EFFICACY AND TOLERABILITY EVALUATION OF CLOFARABINE, CYTARABINE AND LIPOSOMAL DOXORUBICIN IN CHILDREN WITH EITHER LYMPHOBLASTIC OR MYELOID RELAPSED OR REFRACTORY ACUTE LEUKEMIA AND IN CHILDREN WITH SECONDARY ACUTE MYELOID LEUKEMIARELAPSED/REFRACTORY PEDIATRIC ACUTE EITHER LYMPHOBLASTIC OR MYELOID LEUKEMIA AND SECONDARY ACUTE MYELOID LEUKEMIA.MedDRA version: 14.1Level: LLTClassification code 10060356Term: Acute myeloid leukaemia without mention of remissionSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10059034Term: Acute myeloid leukaemia recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10060352Term: Acute lymphoid leukaemia without mention of remissionSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10063621Term: Acute lymphoblastic leukaemia recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-004893-28-ITAZIENDA SANITARIA OSPEDALIERA O.I.R.M. - S. ANNA