Bendamustine Plus Rituximab Versus CHOP Plus Rituximab

Follicular Lymphomas Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00991211
• Other study ID #: NHL 1-2003
• Status: Completed
• Phase: Phase 3
• First received: October 6, 2009
• Last updated: March 13, 2012
• Start date: January 2004
• Est. completion date: August 2009

Study information

• Verified date: October 2009
• Source: University of Giessen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 549
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Follicular Lymphomas
• Immunocytomas
• Leukemia, Lymphocytic, Chronic, B-Cell
• Lymphocytic Lymphomas
• Lymphoma
• Lymphoma, B-Cell, Marginal Zone
• Lymphoma, Follicular
• Lymphoma, Non-Hodgkin
• Marginal Zone Lymphomas
• Non-Hodgkin Lymphomas

Intervention

Drug:
• Bendamustine
Comparison of Bendamustine + Rituximab with 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 as standard Chemotherapy

Locations

Country	Name	City	State
Germany	StiL Head Office; Justus-Liebig-University	Giessen

Sponsors (1)

Lead Sponsor	Collaborator
University of Giessen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		observation 3 years or significant differences between two arms	Yes
Secondary	Determination and comparison of remission rates, of toxicity, infectious complications, overall survival, EFS, TTNT, capacity of peripheral blood stem cell mobilization		ongoing	Yes

External Links

•   Homepage of the Study group of indolent lymphomas (StiL)