Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab

University of Giessen

Status and phase: Completed; Phase 3

Conditions: Non-Hodgkin's Lymphoma; Mantle Cell Lymphoma

Treatments: Drug: Fludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4w; Drug: Bendamustine plus Rituximab

Study type: Interventional

Funder types: Other

Identifiers

NCT01456351

NHL 2-2003

Details and patient eligibility

About

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.

Enrollment: 230 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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230 participants in 2 patient groups

Bendamustine plus Rituximab

Experimental group

Description:

Bendamustine 90 mg/m² d 1+2 + Rituximab 375 mg/m² d 1 q4w

Treatment:

Drug: Bendamustine plus Rituximab

Fludarabine plus Rituximab

Active Comparator group

Description:

Fludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4w

Treatment:

Drug: Fludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4w