First-line treatment for different subgroups of lymphomas

• Conditions: Indolent Non-Hodgkin Lymphomas, in particular follicular lymphomas, as well as marginal zone lymphomas, immunocytomas (Waldenström’s macroglobulinaemia) and mantle cell lymphomas; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2008-005859-16-DE
• Lead Sponsor: StiL Forschungs-GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-20
• Last Update Posted: 29 May 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 874

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
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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified