Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Giessen
• Treatments: Bendamustine Hydrochloride; Fludarabine; Fludarabine phosphate; Rituximab; Vidarabine

Criteria

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