Bendamustine Plus Rituximab Versus CHOP Plus Rituximab

Last updated: August 20, 2024
Sponsor: University of Giessen
Overall Status: Completed

Phase

3

Condition

Lymphoma

Chronic Lymphocytic Leukemia

Follicular Lymphoma

Treatment

Bendamustine

Standard chemotherapy CHOP + Ritiximab

Clinical Study ID

NCT00991211
NHL 1-2003
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with histological verified CD20-positive B-Cell-Lymphomas of the followingentities:

  • 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

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 expandingtwo 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 orbilirubin 3 x ULN, except caused by lymphoma.

Study Design

Total Participants: 549
Treatment Group(s): 2
Primary Treatment: Bendamustine
Phase: 3
Study Start date:
January 01, 2004
Estimated Completion Date:
August 31, 2009

Study 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.

Connect with a study center

  • StiL Head Office; Justus-Liebig-University

    Giessen, 35392
    Germany

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.