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Bendamustine Plus Rituximab Versus CHOP Plus Rituximab

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ClinicalTrials.gov Identifier: NCT00991211
Recruitment Status : Completed
First Posted : October 7, 2009
Last Update Posted : March 14, 2012
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 the first line therapy of low malignant and mantle cell lymphomas with bendamustine plus rituximab is comparable (non inferior) with CHOP plus rituximab with regard to progression free survival (PFS).

Condition or disease Intervention/treatment Phase
Non-Hodgkin Lymphomas Follicular Lymphomas Immunocytomas Lymphocytic Lymphomas Marginal Zone Lymphomas Drug: Bendamustine Drug: Standard chemotherapy CHOP + Ritiximab Phase 3

Detailed Description:
The 4 agent chemotherapy (CTX) CHOP (cyclophosphamide, doxorubicin, vincristine prednisone) in combination with the monoclonal anti-CD20 antibody rituximab (CHOP-R) represents a standard CTX for the treatment of lymphomas of high or low malignancy. The combination of bendamustine and rituximab (B-R) is also highly effective with a more advantageous toxicity profile. If B-R could be shown to be non inferior to CHOP-R, this could improve the quality of life of the patient and possibly also the prognosis.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 549 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomised Multicenter Study for Therapy Optimization (First Line) of Advanced Progredient, Low Malignant Non-Hodgkin Lymphomas and Mantle Cell Lymphomas
Study Start Date : January 2004
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

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 + Rituximab
Bendamustine 90 mg/m² d 1+2 + Rituximab 375 mg/m² d 1 q4w
 Drug: Bendamustine
Comparison of Bendamustine + Rituximab with CHOP + Rituximab
Other Name: Ribomustin, Treanda
Active Comparator: CHOP + Rituximab
Cyclophosphamid 750 mg/m² d 1 + Doxorubicin 50 mg/m² d 1 + Vincristin 1,4 mg/m² max. 2 mg d 1 + Prednison 100 mg absolute p.o. d 1-5 + Rituximab 375 mg/m² d 1 q3w
 Drug: Standard chemotherapy CHOP + Ritiximab
Cyclophosphamid 750 mg/m² d 1 + Doxorubicin 50 mg/m² d 1 + Vincristin 1,4 mg/m² max. 2 mg d 1 + Prednison 100 mg absolute p.o. d 1-5 + Rituximab 375 mg/m² d 1 q3w as standard Chemotherapy
Other Names:
  • Endoxan(R), Cyclostin(R) = Cyclophosphamide
  • Adriamycin(R) Doxorubicin
  • Oncovin(R) Vincristine
  • Prednison
  • Rituxan(R), MabThera(R) = Rituximab


Outcome Measures
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Primary Outcome Measures :
  1. Progression free survival [ Time Frame: observation 3 years or significant differences between two arms ]

Secondary Outcome Measures :
  1. Determination and comparison of remission rates, of toxicity, infectious complications, overall survival, EFS, TTNT, capacity of peripheral blood stem cell mobilization [ Time Frame: ongoing ]

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
  • No prior therapy with cytotoxics,interferon or monoclonal antibodies
  • Need for therapy, except mantle cell lymphomas
  • Stadium III 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, potential curative radiation therapy
  • Pretreatment except a unique local delimited radiation (radiation fiel not expanding two adjacent lymph node regions

  • 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.
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): NCT00991211


Locations
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Germany
StiL Head Office; Justus-Liebig-University
Giessen, Germany, 35392
Sponsors and Collaborators
University of Giessen
Investigators
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Principal Investigator: Mathias Rummel, Dr. Study Group of indolent Lymphom,as (StiL)
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, Study Group indolent Lymphomas (StiL), University of Giessen
ClinicalTrials.gov Identifier: NCT00991211    
Other Study ID Numbers: NHL 1-2003
First Posted: October 7, 2009    Key Record Dates
Last Update Posted: March 14, 2012
Last Verified: October 2009
Keywords provided by Jurgen Barth, University of Giessen:
Comparison
Bendamustine + Rituximab
CHOP + Rituximab
Progression free survival
 Overall survival
Toxicity
Safety
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell, Marginal Zone
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Leukemia, B-Cell
Leukemia, Lymphoid
Leukemia
Hematologic Diseases
 Chronic Disease
Disease Attributes
Pathologic Processes
Cyclophosphamide
Bendamustine Hydrochloride
Doxorubicin
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents