Clofarabine added to prephase and consolidation therapy in acute lymphoblastic leukemia in adults. - HOVON 100 ALL / EORTC 06083

HOVON Foundation0 个研究点目标入组 340 人开始时间: 2010年3月22日最近更新: 2016年1月25日

适应症

试验速览

暂无简介。

•- Patients aged 18 to 70 years inclusive
•- Primary previously untreated B or T-lineage ALL (excluding ALL with mature B-cell
•phenotype, but including Philadelphia positive or BCR-ABL positive ALL) or previously untreated T-LBL (pretreatment with prednisolone for 7 days is allowed)
•- WHO performance status 0 – 2
•- Adequate renal and hepatic function tests as indicated by the following laboratory
•- Serum creatinine =1.0 mg/dl (= 88.7 micromol/L); if serum creatinine >1.0 mg/dl
•(>88.7 micromol/L), then the glomerular filtration rate (GFR) must be
•>60 ml/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease
•equation where the predicted GFR (ml/min/1.73 m2) = 186 x (Serum Creatinine in
•mg/dl)-1.154 x (age in years)-0.023 x (0.742 if patient is female) x (1.212 if
•patient is black)
•NOTE: if serum creatinine is measured in micromol/L, recalculate it in mg/dl
•according to the equation: 1 mg/dl = 88.7 micromol/L) and used above mentioned
•- Serum bilirubin = 1.5 × upper limit of normal (ULN)
•- Aspartate transaminase (AST)/alanine transaminase (ALT) = 2.5 × ULN
•- Alkaline phosphatase = 2.5 × ULN
•- Negative pregnancy test at inclusion, if applicable
•- Written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 326
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•- Mature surface Ig positive B-cell leukemia/lymphoma
•- Acute undifferentiated leukemia
•- Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive
•heart failure or symptomatic ischemic heart disease)
•- Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix D)
•- Severe neurological or psychiatric disease
•- History of active malignancy during the past 5 years with the exception of basal
•carcinoma of the skin or stage 0 cervical carcinoma
•- Active, uncontrolled infection
•- Patient known to be HIV-positive
•- Patient is a lactating woman
•- Any psychological, familial, sociological and geographical condition potentially
•hampering compliance with the study protocol and follow-up schedule
•- Unwilling or not capable to use effective means of birth control

发起方

HOVON Foundation