Anti-CD20 monoclonal antibody therapy for type II mixed cryoglobulinemia syndrome versus best available treatment: a phase III controlled study

niversity of Udine (Italy)0 个研究点目标入组 124 人开始时间: 2012年2月3日最近更新: 2017年11月27日

适应症

试验速览

暂无简介。

•1. Patients with CV with type II cryoglobulins
•2. HCV? related or unrelated, classified according to published criteria
•3. With positive serum cryoglobulins
•4. Suffered from severe active CV manifestations, i.e., skin ulcers, active glomerulonephritis, or worsening or refractory peripheral neuropathy
•5. In patients with HCV-related CV, study inclusion implied that antiviral therapy with interferon plus ribavirin had failed, had been poorly tolerated, or was considered contraindicated
•6. Patients aged 18-80 years
•7. Negative for antibodies against the human immunodeficiency virus (HIV), hepatitis B virus core antigen, and for hepatitis B virus surface antigen

•1. Active CV manifestations with immediate risk for patient survival
•2. Acute renal failure or rapidly progressive glomerulonephritis
•3. Severe concomitant uncontrolled illness CV-unrelated
•4. Active or recurrent infections
•5. History of cancer (except for CV-related indolent B-cell lymphoproliferation in the bone marrow, not requiring treatment)
•6. Alcohol or drug abuse
•7. Serum creatinin > 4 mg/dl
•8. AST or ALT > 3 times the upper limit of normal
•9. Haemoglobin < 8 g/dl
•10. Neutrophils < 1000/mmc or total leukocytes < 1500/mmc
•11. Platelets < 40.000/mmc
•12. History of severe allergic reactions to monoclonal antibodies
•13. Pregnancy (if reproductive potential, an accepted birth control method was required)
•14. Previous treatment with RTX
•15. Previous failure of all the following:
•15.1. High dose glucocorticoids
•15.2. Plasma exchange
•15.3. Cyclophosphamide
•15.4. Azathioprine

发起方

niversity of Udine (Italy)