EUCTR2008-005859-16-DE
Active, not recruiting
Not Applicable
Prospective randomized Multicenter study in first-line treatmentof Advanced progredIeNT follicular And other IndoleNt and mantle cell lymphomas - MAINTAI
StiL Forschungs-GmbH0 sites874 target enrollmentNovember 20, 2008
ConditionsIndolent Non-Hodgkin Lymphomas, in particular follicular lymphomas, as well as marginal zone lymphomas, immunocytomas (Waldenström’s macroglobulinaemia) and mantle cell lymphomasTherapeutic area: Diseases [C] - Cancer [C04]
DrugsMabthera(R)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Indolent Non-Hodgkin Lymphomas, in particular follicular lymphomas, as well as marginal zone lymphomas, immunocytomas (Waldenström’s macroglobulinaemia) and mantle cell lymphomas
- Sponsor
- StiL Forschungs-GmbH
- Enrollment
- 874
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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