EUCTR2010-019742-12-IT进行中（未招募）1 期
A Phase II study with a sequential clofarabine-cyclophosphamide combination schedule as salvage therapy for refractory and relapsed acute lymphoblastic leukemia (ALL) in adult patients - GIMEMA LAL1610
G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO0 个研究点开始时间: 2012年6月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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 18-60 years.
- •-ALL with B-/T precursor phenotype refractory to first line therapy.
- •-ALL with B-/T precursor phenotype with 1st isolated bone marrow relapse, occurring = 24 months from the achievement of first CR, after chemotherapy or hematopoietic stem cell transplantation (HSCT) defined as follows:
- •=5% leukemic blasts in the bone marrow not attributable to another cause (e.g. marrow regeneration); if there are no circulating blasts and the bone marrow contains 5-20% leukemic blasts, a repeat bone marrow performed at least one week later is necessary to confirm relapse.
- •-An ECOG performance status 0-2 or reversible ECOG 3 score following intensive care of complications.
- •-Adequate hepatic and renal function, unless considered due to organ leukemic involvement:
- •?Serum creatinine <1.5 mg/dl; if serum creatinine >1.5 mg/dl, 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.
- •?Serum bilirubin =1.5 x upper limit of normal (ULN).
- •?Aspartate transaminase (AST)/alanine transaminase (ALT) =2.5 x ULN.
- •-Alkaline phosphatase =2.5 x ULN.
- •-Women of childbearing potential must have a negative serum pregnancy
- •-Signed written informed consent according to ICH/EU/GCP and national local laws.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 27
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Prior exposure to Clofarabine or, in primary refractory patients, to Cyclophosphamide during the induction courses.
- •-Patients relapsed >24 months from first CR.
- •-2nd or subsequent bone marrow relapse
- •- Philadelphia chromosome-positive (Ph+) ALL.
- •-Diagnosis of Burkitt-type/B-ALL, or B-/T-lymphoblastic lymphoma with <25% bone marrow involvement.
- •-Concurrent or isolated central nervous system (CNS) relapse.
- •-Pre-existing, uncontrolled pathology such as cardiac disease (congestive/ischemic, acute myocardial infarction within the past 3 months, untreatable arrhythmias, NYHA classes III and IV).
- •-Severe neurological or psychiatric disorder that impairs the patient’s ability to understand and sign the informed consent, or to cope with the intended treatment plan.
- •-Active uncontrolled systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
- •-HIV positive serology or active hepatitis infection.
- •-Concurrent diagnosis of active cancer requiring concurrent chemotherapy and/or radiotherapy, and/or with a life expectancy <1 year.
- •-Patients who are pregnant (women of childbearing potential must have a negative serum pregnancy test). Post-menopausal women must be amenorrhoic for at least 24 months to be considered of non-childbearing potential. Male and female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drugs
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