Bendamustine Plus Rituximab Versus CHOP Plus Rituximab

University of Giessen

Status and phase: Completed; Phase 3

Conditions: Non-Hodgkin Lymphomas; Lymphocytic Lymphomas; Immunocytomas; Follicular Lymphomas; Marginal Zone Lymphomas

Treatments: Drug: Standard chemotherapy CHOP + Ritiximab; Drug: Bendamustine

Study type: Interventional

Funder types: Other

Identifiers

NCT00991211

NHL 1-2003

Details and patient eligibility

About

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).

Full 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.

Enrollment: 549 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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549 participants in 2 patient groups

Bendamustine + Rituximab

Experimental group

Description:

Bendamustine 90 mg/m² d 1+2 + Rituximab 375 mg/m² d 1 q4w

Treatment:

Drug: Bendamustine

CHOP + Rituximab

Active Comparator group

Description:

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

Treatment:

Drug: Standard chemotherapy CHOP + Ritiximab