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Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01456351
Recruitment Status : Completed
First Posted : October 20, 2011
Last Update Posted : February 12, 2013
Sponsor:
Information provided by (Responsible Party):
Jurgen Barth, University of Giessen

Study Description
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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.

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Mantle Cell Lymphoma Drug: Bendamustine plus Rituximab Drug: Fludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4w Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomised Multicenter Study for Therapy Optimization of Recurrent, Progressive Low Grade Non-Hodgkin Lymphomas and Mantle Cell Lymphomas
Study Start Date : September 2003
Actual Primary Completion Date : August 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Bendamustine plus Rituximab
Bendamustine 90 mg/m² d 1+2 + Rituximab 375 mg/m² d 1 q4w
 Drug: Bendamustine plus Rituximab
Bendamustine 90 mg/m² d 1+2 + Rituximab 375 mg/m² d 1 q4w for maximum 6 cycles
Active Comparator: Fludarabine plus Rituximab
Fludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4w
 Drug: 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 for maximum 6 cycles


Outcome Measures
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Primary Outcome Measures :
  1. Event Free Survival [ Time Frame: 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 :
  1. Remission Rates [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01456351


Locations
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Germany
StiL Head Office; Justus-Liebig-University
Giessen, Germany, 35392
Sponsors and Collaborators
University of Giessen
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jurgen Barth, Professor Mathias Rummel, University of Giessen
ClinicalTrials.gov Identifier: NCT01456351    
Other Study ID Numbers: NHL 2-2003
First Posted: October 20, 2011    Key Record Dates
Last Update Posted: February 12, 2013
Last Verified: February 2013
Keywords provided by Jurgen Barth, University of Giessen:
Event free survival
Remission rates
Toxicity
 Overall survival
Efficiency costs
Recurrent low grade
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
 Fludarabine
Bendamustine Hydrochloride
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents