Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab

Phase 3

Completed

• Conditions: Non-Hodgkin's Lymphoma; Mantle Cell Lymphoma
• Interventions: Drug: Fludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4w; Drug: Bendamustine plus Rituximab

• Registration Number: NCT01456351
• Lead Sponsor: University of Giessen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Primary Completion: 2010-08
• Study Completion: 2010-12
• Study First Submitted: 2011-10-11
• Study First Submitted QC: 2011-10-19
• Study First Posted: 2011-10-20
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fludarabine plus Rituximab	Fludarabine 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
Bendamustine plus Rituximab	Bendamustine plus Rituximab	Bendamustine 90 mg/m² d 1+2 + Rituximab 375 mg/m² d 1 q4w

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

StiL Head Office; Justus-Liebig-University; 🇩🇪 Giessen, Germany