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Bendamustine Plus Rituximab Versus CHOP Plus Rituximab

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jurgen Barth, University of Giessen
ClinicalTrials.gov Identifier:
NCT00991211
First received: October 6, 2009
Last updated: March 13, 2012
Last verified: October 2009
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Further study details as provided by University of Giessen:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: observation 3 years or significant differences between two arms ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determination and comparison of remission rates, of toxicity, infectious complications, overall survival, EFS, TTNT, capacity of peripheral blood stem cell mobilization [ Time Frame: ongoing ] [ Designated as safety issue: Yes ]

Enrollment: 549
Study Start Date: January 2004
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00991211

Locations
Germany
StiL Head Office; Justus-Liebig-University
Giessen, Germany, 35392
Sponsors and Collaborators
University of Giessen
Investigators
Principal Investigator: Mathias Rummel, Dr. Study Group of indolent Lymphom,as (StiL)
  More Information

Additional Information:
Homepage of the Study group of indolent lymphomas (StiL)  This link exits the ClinicalTrials.gov site

No publications provided by University of Giessen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jurgen Barth, Study Group indolent Lymphomas (StiL), University of Giessen
ClinicalTrials.gov Identifier: NCT00991211     History of Changes
Other Study ID Numbers: NHL 1-2003
Study First Received: October 6, 2009
Last Updated: March 13, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Giessen:
Comparison
Bendamustine + Rituximab
CHOP + Rituximab
Progression free survival
 Overall survival
Toxicity
Safety

Additional relevant MeSH terms:
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell, Marginal Zone
Lymphoma, Mantle-Cell
Leukemia, B-Cell
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Lymphoma, B-Cell
Cyclophosphamide
Rituximab
Nitrogen Mustard Compounds
Bendamustine
Doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013