Single-arm phase II to evaluate the safety and efficacy of Campath in combination with high-dose methylprednisolone in CLL patients with deletion of the p53 tumour suppressor gene.

niversity of Liverpool (UK)0 个研究点目标入组 40 人开始时间: 2010年8月19日最近更新: 2018年11月12日

适应症

试验速览

•1. At least 18 years old, either sex
•2. Written informed consent
•3. Confirmed diagnosis of CLL or SLL (small mature lymphocytes in blood, bone marrow or lymph node expressing CD19, CD5, CD23, weak CD79b, and weak clonally restricted immunoglobulin light chain)
•4. p53 deletion by FISH in at least 20% of leukaemia cells
•5. Treatment is indicated (Binet stage B or C, or stage A with a lymphocyte doubling time of less than 6 months, or disease-related symptoms or complications irrespective of clinical stage)
•6. World Health Organization (WHO) performance status 0, 1 or 2
•7. Both untreated and previously treated patients are eligible for study

•1. Active infection
•2. Known human immunodeficiency virus (HIV) infection
•3. Past history of anaphylaxis following exposure to rat or mouse CDR-grafted humanised monoclonal antibodies
•4. Less than 3 weeks since prior chemotherapy
•5. Use of prior investigational agents within 6 weeks
•6. Pregnancy or lactation
•7. Uncontrolled diabetes mellitus
•8. Uncontrolled hypertension
•9. Active peptic ulcer disease
•10. Other severe concurrent diseases or mental disorders
•11. Serum urea or creatinine more than twice the upper limit of normal (unless due to ureteric obstruction or renal infiltration by CLL/SLL)
•12. Serum bilirubin more than twice the upper limit of normal (unless due to haemolysis or liver infiltration with CLL/SLL)
•13. Persisting severe cytopenias due to previous therapy rather than disease (neutrophils less than 0.5 x 10^9/l or platelets less than 50 x 10^9/l)

发起方

niversity of Liverpool (UK)