Significance of Duration of Maintenance Therapy With Rituximab in Non-Hodgkin Lymphomas
Prospective Randomized Multicenter Study in First-line Treatment of Advanced progredIeNT Follicular And Other IndoleNt and Mantle Cell Lymphomas
The purpose of this study is to determine if an extended maintenance therapy with Rituximab in follicular and a maintenance therapy in other indolent and mantle cell lymphomas has advantages compared to a shorter or no maintenance therapy.
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.
Progression free survival
Remission rate and duration; event free-, progression free-, disease free- and over all survival
Study Arms / Comparison Groups
Description: Follicular Lymphomas: Rituximab 375 mg/m² for additional 2 years after 2 years of standard maintainance All other lymphomas: Rituximab 375 mg/m² for 2 years as maintainance. From 2014 only Morbus Waldenstroem: Rituximab 1.400 mg absolute s. c. injection
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
April 1, 2009
Primary Completion Date
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 .
18 Years - 80 Years
Accepts Healthy Volunteers
Mathias Rummel, Dr, ,
Mathias Rummel, Dr, Principal Investigator, University of Giessen