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

HOVO0 个研究点目标入组 285 人开始时间: 待定最近更新: 2024年5月6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 prednisone 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 formula.
•- 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

•- 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)
•- 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 (all men, all premenopausal women under the age of 50 need contraception for two years after the last period, and women older than 50 yrs for at least one year)

发起方

HOVO