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Completed

NCT Number: NCT00991211

Bendamustine Plus Rituximab Versus CHOP Plus Rituximab

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).

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Key information

Conditions

Non-Hodgkin Lymphomas Chronic Disease Disease Attributes Follicular Lymphomas Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunocytomas Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphocytic Lymphomas Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Marginal Zone Lymphomas Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

StiL Head Office; Justus-Liebig-University

Giessen, 35392, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bendamustine

Drug

Comparison of Bendamustine + Rituximab with CHOP + Rituximab

Other names: Ribomustin, Treanda

Standard chemotherapy CHOP + Ritiximab

Drug

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

Primary outcomes

  1. Progression free survival

    Time frame: observation 3 years or significant differences between two arms

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Giessen

Other

Registry information

Official study title

Prospective Randomised Multicenter Study for Therapy Optimization (First Line) of Advanced Progredient, Low Malignant Non-Hodgkin Lymphomas and Mantle Cell Lymphomas

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Oct 7, 2009
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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