Bendamustine Plus Rituximab Versus CHOP Plus Rituximab

Phase 3

Completed

• Conditions: Marginal Zone Lymphomas; Non-Hodgkin Lymphomas; Follicular Lymphomas; Immunocytomas; Lymphocytic Lymphomas
• Interventions: Drug: Standard chemotherapy CHOP + Ritiximab; Drug: Bendamustine

• Registration Number: NCT00991211
• Lead Sponsor: University of Giessen

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).

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 Timeline

• Study Start: 2004-01
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Study First Submitted: 2009-10-06
• Study First Submitted QC: 2009-10-06
• Study First Posted: 2009-10-07
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 549

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHOP + Rituximab	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
Bendamustine + Rituximab	Bendamustine	Bendamustine 90 mg/m² d 1+2 + Rituximab 375 mg/m² d 1 q4w

Primary Outcome Measures

Name	Time	Method
Progression free survival	observation 3 years or significant differences between two arms

Secondary Outcome Measures

Name	Time	Method
Determination and comparison of remission rates, of toxicity, infectious complications, overall survival, EFS, TTNT, capacity of peripheral blood stem cell mobilization	ongoing

Trial Locations

Locations (1)

StiL Head Office; Justus-Liebig-University; 🇩🇪 Giessen, Germany