A multicenter Phase I/II trial investigating the safety and efficacy (CR rate and OS) of low dose AraC with Clofarabine in patients =60 years with AML not eligible for conventionalChemotherapy - Clofarabine

niversität Leipzig0 个研究点目标入组 13 人2010年10月7日

适应症MedDRA - 10000886, akute myeloische Leukämie, acute myeloid leukemia C92.0 Acute myeloblastic leukaemia [AML]

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: MedDRA - 10000886, akute myeloische Leukämie, acute myeloid leukemia
发起方: niversität Leipzig
入组人数: 13
状态: 进行中（未招募）
最后更新: 去年

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2010年10月7日

结束日期

2013年8月25日

最后更新

去年

研究类型

Interventional

性别

All

研究者

发起方

niversität Leipzig

入排标准

入选标准

•1\.Diagnosis of AML as defined by WHO
•2\.Primary or secondary AML
•3\.Age \=60 years
•4\.Not eligible for standard/”curative” chemotherapy as described at the end of this section in refer\-ence tables in section 4\.3\.
•5\.Adequate renal and hepatic functions as indicated by ALL of the following laboratory values:
•a.Serum creatinine \<\=1\.0 mg/dL (\<\=88,4 µmol/l) or
•if serum creatinine \>1\.0 mg/dL (\>88,4 µmol/l), then the estimated glomerular filtration rate (GFR) must be \>60 mL/min/1\.73 m2 as calculated by the Modification of Diet in Renal Disease equation where Predicted GFR (ml/min/1\.73 m2\) \= 186 x (Serum Creatinine)\-1\.154 x (age in years)\-0\.023 x (0\.742 if patient is female) x (1\.212 if patient is black)
•b.Serum bilirubin \=1\.5 mg/dL (17,1 µmol/l) × upper limit of normal (ULN)
•c.Aspartate transaminase (AST)/ alanine transaminase (ALT) \<\=2\.5 × ULN
•d.Alkaline phosphatase \<\=2\.5 × ULN

排除标准

•1\.Diagnosis of AML M3
•2\.Current concomitant chemotherapy, radiation therapy, or immunotherapy other than described in the trial protocol.
•3\.Use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry. The patient must have recovered from all acute toxicities from any previous therapy.
•4\.Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo treatment.
•5\.Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
•6\.Hypersensitivity to Clofarabine, AraC or one of their components.
•7\.Pregnant or nursing women.
•8\.Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
•9\.Have had a diagnosis of another malignancy, unless the patient has been disease\-free for at least 3 years following the completion of curative intent therapy, with the following exceptions:
•9a.Patients with treated non\-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease\-free duration, are eligible for this study if definitive treatment for the condition has been completed.