Brief Title
Bendamustine Plus Rituximab Versus CHOP Plus Rituximab
Official Title
Prospective Randomised Multicenter Study for Therapy Optimization (First Line) of Advanced Progredient, Low Malignant Non-Hodgkin Lymphomas and Mantle Cell Lymphomas
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 Phase
Phase 3
Study Type
Interventional
Primary Outcome
Progression free survival
Secondary Outcome
Determination and comparison of remission rates, of toxicity, infectious complications, overall survival, EFS, TTNT, capacity of peripheral blood stem cell mobilization
Condition
Non-Hodgkin Lymphomas
Intervention
Bendamustine
Study Arms / Comparison Groups
Bendamustine + Rituximab
Description: Bendamustine 90 mg/m² d 1+2 + Rituximab 375 mg/m² d 1 q4w
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
549
Start Date
January 2004
Completion Date
August 2009
Primary Completion Date
August 2009
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Mathias Rummel, Dr., ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT00991211
Organization ID
NHL 1-2003
Responsible Party
Principal Investigator
Study Sponsor
University of Giessen
Study Sponsor
Mathias Rummel, Dr., Principal Investigator, Study Group of indolent Lymphom,as (StiL)
Verification Date
October 2009