Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab

University of Giessen230 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

230

Conditions

Non-Hodgkin's Lymphoma Mantle Cell Lymphoma

Interventions

Bendamustine plus RituximabDRUG

Bendamustine 90 mg/m² d 1+2 + Rituximab 375 mg/m² d 1 q4w for maximum 6 cycles

Fludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4wDRUG

Fludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4w for maximum 6 cycles

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

StiL Head Office; Justus-Liebig-University

Giessen, Germany

Outcomes

Primary Outcomes

Event Free Survival

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

Time frame: Observation till event or death, minimum 1 year

Secondary Outcomes

Remission Rates

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

Time frame: Observation till event or death, minimum 1 year

Data from ClinicalTrials.gov

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