Prospective randomized Multicenter study in first-line treatmentof Advanced progredIeNT follicular And other IndoleNt and mantle cell lymphomas - MAINTAI

StiL Forschungs-GmbH0 个研究点目标入组 874 人开始时间: 2008年11月20日最近更新: 2012年5月29日

适应症

试验速览

暂无简介。

•Patients with histological verified CD20-positive B-cell-lymphoma of the following entities:
•follicular lymphoma
•immunocytoma / Waldenström’s macroglobulinaemia and small-cell lymphocytic lymphoma without leukaemic phase of the disease
•marginal zone lymphoma
•mantle cell lymphoma
•no pretreatment with cytostatics, interferon or monoclonal antibodies
•in need for therapy, except mantle cell lymphoma
•stages III or IV or stage II bulky disease
•performance status (WHO) 0-2
•minimum age 18 years maximum age 80 years
•negative pregnancy test, contraception for women of child-bearing age
•histology not older than 6 month – mandatory
•patients written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 450
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 424

•Patients not meeting the criteria of E 3
•Potential curative radiotherapy as alternative option
•Pre-treatment except singular locally confined radiotherapy (radiation field not larger than two adjacent lymph node regions)
•concomitant disease which impedes the study equitable therapy like: severe, medicinal uncontrollable hypertension, severe disorder of the heart or lung or liver or kidney, except if caused by the lymphoma
•patients with proven HIV-infection
•active and replicating hepatitis-infection
•severe psychiatric disorder
•missing or anticipation of missing compliance
•Pregnant or breastfeeding women
•Patients with a second malignoma or malignant disease in their history, if surgery is anticipated not to be curable.

发起方

StiL Forschungs-GmbH