ISRCTN65655917已完成未知

Chimeric anti-CD20 monoclonal antibody (Mabthera) in remission induction and maintenance treatment of relapsed follicular non-Hodgkin's lymphoma (NHL): a phase III randomised clinical trial (Intergroup Collaborative Study)

European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)0 个研究点目标入组 465 人开始时间: 2002年8月19日最近更新: 2018年11月19日

适应症

试验速览

•1. Patients with Ann Arbour stages III or IV follicular NHL (at initial diagnosis) who have relapsed after a minimum of two adequate non-anthracycline containing systemic chemotherapy regimens. Patients pre-treated with other chemotherapy regimens are not eligible for this trial.
•2. Patients should have achieved remission on at least one of the prior regimens (i.e. either on the first or second regimen)
•3. Remission duration upon one of the prior regimens should have been at least 3 months
•4. Previous treatment should have been at least 4 month of single agent therapy (e.g. chlorambucil) and/or at least four consecutive cycles of polychemotherapy (e.g. CVP) or purine analogues. Patients treated with chemotherapy not fulfilling these criteria are not eligible.
•5. Follicular NHL according to the Revised European/American Lymphoma (REAL) classification, i.e. follicle centre lymphoma, follicular (provisional cytological grades I [small cell], II [mixed small cell and large cell], III [large cell])
•6. Must be CD20 positive lymphoma
•7. At least one mass should be present measurable by two perpendicular diameters by either physical or radiological examination
•8. Aged 18 years or above
•9. World Health Organization (WHO) performance status 0, 1 or 2
•10. Patient information and written informed consent according to the rules of the respective country

发起方

European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)