Status:
COMPLETED
Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab
Lead Sponsor:
University of Giessen
Conditions:
Non-Hodgkin's Lymphoma
Mantle Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 surv...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT01456351
Start Date
September 1 2003
End Date
December 1 2010
Last Update
August 22 2024
Active Locations (1)
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1
StiL Head Office; Justus-Liebig-University
Giessen, Germany, 35392