A Prospective Multicenter Phase II Study of MabThera (Rituximab) Plus 2 Weekly CHOP Followed by Low Dose Total Body Irradiation in Elderly Patients With Diffuse Large B-Cell Lymphoma
Phase 2
60 Years
N/A
60 Years
N/A
Not Enrolling
Both
Non Hodgkin's Lymphoma
Both
Non Hodgkin's Lymphoma
Trial Information
A Prospective Multicenter Phase II Study of MabThera (Rituximab) Plus 2 Weekly CHOP Followed by Low Dose Total Body Irradiation in Elderly Patients With Diffuse Large B-Cell Lymphoma
Inclusion Criteria:
- previously untreated, pathology verified aggressive non-Hodgkin lymphoma of the
diffuse large B-cell type according to the WHO classification. Age between 60 years
and 80 years.Positive for an anti-CD20 antibody. Good performance status and normal
initial normal blood count.
Exclusion Criteria:
- Patients with previous lymphoma associated with immune suppression of any sort.
Diagnosis or history of indolent lymphoma or other malignancies. Marked impairment of
any vital organ such as the heart, lung, liver or kidneys.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Authority:
Denmark: Ethics Committee
Study ID:
LTBI-NHL-01
NCT ID:
NCT00834951
Start Date:
January 2003
Completion Date:
December 2008
Related Keywords:
- Non Hodgkin's Lymphoma
- Diffuse large B-cell lymphoma
- Elderly patients
- Low dose total body irradiation
- RCHOP14
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
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