ISRCTN86445183已完成不适用

Alemtuzumab as remission induction for adult patients with acute lymphoblastic leukemia in relapse: a randomized phase II study

Dutch Haemato-oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON)0 个研究点目标入组 120 人开始时间: 2006年6月7日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Age 18 - 70 years inclusive
•2. First or second relapse of precursor B-cell ALL (B-ALL) or T-cell (T-ALL) (including Philadelphia chromosome or BCR-ABL tyrosine kinase positive ALL)
•3. Duration of last complete remission at least 6 months
•4. World Health Organization (WHO) performance status 0, 1, or 2
•5. Negative pregnancy test at inclusion if applicable
•6. Written informed consent

•1. Mature B-cell ALL, i.e. Burkitt leukemia/lymphoma
•2. Acute undifferentiated leukemia (AUL)
•3. Treatment with alemtuzumab at any time prior to registration
•4. Intolerance of exogenous protein administration
•5. Central nervous system (CNS) leukemia
•6. Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease)
•7. Severe pulmonary dysfunction (Common Terminology Criteria for Adverse Events [CTCAE] grade III-IV)
•8. Severe neurological or psychiatric disease
•9. Significant hepatic dysfunction (serum bilirubin or transaminases >/= 3 times normal level)
•10. Significant renal dysfunction (serum creatinine >/= 3 times normal level)
•11. Patients with active, uncontrolled infections
•12. Patients with uncontrolled asthma or allergy, requiring oral steroid treatment at the time of registration
•13. Patients known to be human immunodeficiency virus (HIV)-positive
•14. Patient is a lactating woman
•15. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

发起方

Dutch Haemato-oncology Association (Stichting Hemato-Oncologie Volwassenen Nederland) (HOVON)