Mantle Cell Lymphoma, Non-Hodgkin's Lymphoma
Conditions
Keywords
Event free survival, Remission rates, Toxicity, Overall survival, Efficiency costs, Recurrent low grade
Brief summary
The study addresses the question if a therapy with bendamustine plus rituximab is comparable (non inferior) with the well-tried combination of fludarabine plus rituximab with regard to event free survival (EFS) in recurrent low malignant Non-Hodgkin and mantle cell lymphomas.
Interventions
Bendamustine 90 mg/m² d 1+2 + Rituximab 375 mg/m² d 1 q4w for maximum 6 cycles
DRUGFludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4w
Fludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4w for maximum 6 cycles
Sponsors
University of Giessen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with histological verified CD20-positive B-Cell-Lymphomas of the following entities: * Follicular lymphoma grade 1 and 2 * Immunocytoma and lymphoplasmocytic lymphoma * Marginal zone lymphoma, nodal and generalised * Mantle cell lymphoma * lymphocytic lymphoma (CLL without leucaemic characteristics) * non-specified/classified lymphomas of low malignancy * Recurrent disease (remission duration minimum 3 months), independent of type or quantity of prior therapies, except of Rituximab containing regimens, or if remission duration is \> 1 year after Rituximab containing regimen, or refractory to prior therapy (progression under therapy or during 3 months after completion), except refractory disease to purin analogs or Bendamustine * Need for therapy, except mantle cell lymphomas * Stadium II (bulky disease, 7.5 cm), II or IV * Written informed consent * Performance status WHO 0-2 * Histology not older than 6 months
Exclusion criteria
* Patients not establishing all above mentioned prerequisites * Option of a primary, potentially curative radiation therapy * Patients refractory to Rituximab containing regimens * Comorbidities excluding a study conform therapy: heart attack during the last 6 months severe, medicinal not adjustable hypertonia severe functional defects of the heart (NYHA III or IV) lung (WHO grade III or IV) liver or kidney (creatinine \> 2 mg/dl, GOT + GPT or bilirubin 3 x ULN, except caused by lymphoma * Active auto immunohemolytic anemia (AIHA) * HIV positive patients * Active hepatitis infection * Severe psychiatric diseases * No compliance or non-compliance to be expected * Pregnant or breast feeding women * Anamnestic malignancies or secondary malignancies, not proven * Cured/curable by surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Event Free Survival | Observation till event or death, minimum 1 year | From date of randomization until the date of first documented progression, date of detection of a secondary malignancy or date of death from any cause, whichever came first. Minimum 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Remission Rates | Observation till event or death, minimum 1 year | From date of randomization until the date of first documented progression, date of detection of a secondary malignancy or date of death from any cause, whichever came first. Minimum 1 year |
Countries
Germany
Outcome results
None listed