Significance of Duration of Maintenance Therapy With Rituximab in Non-Hodgkin Lymphomas

Results from several randomised studies show a clinical benefit of a maintenance therapy with rituximab in follicular lymphomas. The advantage of a maintenance therapy in other indolent and mantle cell lymphomas is - due to the lower incidence of these diseases- not well investigated.

This study tries to determine the significance of an extended maintenance therapy with rituximab in follicular lymphomas and the significance of a maintenance therapy other indolent and mantle cell lymphomas compared to observation.

Inclusion criteria

• Patients with histological verified CD20-positive B-Cell-Lymphoma of the following entities:

• Follicular Lymphoma Grade 1 and 2
• Lymphoplasmocytic lymphoma / Immunocytoma (Morbus Waldenström) and small cell lymphocytic lymphoma (CLL without leukemic hemogram)
• Marginal zone lymphoma, nodal and extra nodal
• Mantle cell lymphoma
• No prior therapy with cytotoxics, interferon or monoclonal antibodies
• Need for therapy, except mantle cell lymphomas
• Stadium III or IV or Stadium with II bulky disease (> 7 cm diameter, or 3 lesions > 5 cm)
• General condition WHO 0-2
• Age min. 18 years, max. 80 years
• Negative pregnancy test, contraceptives mandatory for women of child-bearing age
• Actual histology, not older than 6 months required
• Written informed consent

Exclusion criteria

• Patients not meeting the inclusion criteria above
• Possibility of a primary radiation therapy with curative intention
• Pretreatment, except a single, localized radiation therapy (radiation field not larger than 2 adjacent lymph node regions)
• Co-morbidities, excluding a therapy according to the protocol:

• severe, medicinal not adjustable hypertension
• severe limited capacity of the heart (NYHA III or IV), the lung (WHO-Grade III or IV), the liver and kidneys (creatinin > 2 mg/dl, GOT and GPT or bilirubin 3 x ULN), except if caused by lymphoma
• severe, medicinal not adjustable diabetes mellitus
• active autoimmune disease
• active infection, requiring antibiotic therapy
• Patients with proven HIV-infection
• Active replicating hepatitis-Infection
• Severe psychiatric diseases
• Lacking or anticipated non-compliance
• Known hypersensitivity against the active components or additives or mouse- proteins
• Pregnant or nursing women
• Patients with a secondary malignancy or malignant disease in his history if, curative surgery can not be doubtless assured .