Follicular Lymphomas, Immunocytomas, Lymphocytic Lymphoma, Mantle-Cell Lymphomas, Marginal Zone Lymphomas, Non-Hodgkin's Lymphoma
Conditions
Keywords
Bendamustine, Rituximab, Significance of maintenance therapy, Efficacy and safety
Brief summary
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.
Detailed description
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.
Interventions
DRUGRituximab
Follicular Lymphomas: induction therapy with bendamustine + rituximab. If CR or PR: Maintenance therapy with rituximab every 2 months for 4 years Immunocytomas, marginal zone and mantle cell lymphomas: induction therapy with bendamustine + rituximab If CR or PR: Maintenance therapy with rituximab every 2 months for 2 years
DRUGRituximab / observation
Follicular Lymphomas:induction therapy with bendamustine + rituximab If CR or PR: Maintenance therapy with rituximab every 2 months for 2 years (standard) Immunocytomas, marginal zone and mantle cell lymphomas: induction therapy with bendamustine + rituximab If CR or PR: observation (standard)
Sponsors
Sponsor GmbH
Jurgen Barth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | 5 years and ongoing | Time from randomization until progress or death of any course |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Remission rate and duration; event free-, progression free-, disease free- and over all survival | 5 years and ongoing | Time from randomization until treatment failure due to progression or not achieving any remission; time from achievin CR or PR until progression or relapse |
Countries
Germany
Outcome results
None listed