Phase I escalation study of clofarabine (Clolar®) and liposomal daunorubicin (DaunoXome®) in childhood and adolescent acute myeloid leukaemia

niversity of Birmingham (UK)0 个研究点目标入组 18 人开始时间: 2009年2月5日最近更新: 2017年4月18日

适应症

试验速览

暂无简介。

•1. Diagnosis of acute myelogenous leukaemia (AML)
•2. Patients must be in first relapse within 12 months of initial diagnosis or refractory to induction therapy or be in second or subsequent relapse
•3. Patients with refractory AML following induction must be greater than 20% blasts in the bone marrow
•4. Age must be between 6 months to less than 18 years old, either sex
•5. Karnofsky or Lansky score of greater than 50
•6. Patients of childbearing potential must have a negative pregnancy test and agree to use an effective birth control or evidence of post-menopausal status. Post-menopausal status is defined as either radiation-induced oophorectomy with last menses greater than 1 year ago; chemotherapy induced menopause with 1 year interval since last menses.
•7. Normal renal function
•8. Normal hepatic function
•9. Cardiac function defined as: shortening fraction of greater than 29% by echocardiogram left ventricular ejection fraction (LVEF) greater than 58%

•1. First relapse greater than 1 year from their initial diagnosis of AML
•2. Patients whose previous daunorubicin equivalent exposure equals or exceeds 450 mg/m^2
•3. Isolated extramedullary leukaemia
•4. Symptomatic central nervous system (CNS) involvement
•5. Any evidence of severe or uncontrolled systemic conditions
•6. Concurrent treatment or administration of any other experimental drug or with any other cancer therapy
•7. Patients unable to be regularly followed up
•8. Patient with expected non-compliance to toxicity management guidelines

发起方

niversity of Birmingham (UK)