Diffuse Large Cell Lymphoma Clinical Trial
Official title:
Gemcitabine-oxaliplatin Plus Rituximab (R-GEMOX) in Refractory/Relapsed Patients With CD 20 Positive Diffuse Large B-cell Lymphoma, Non Eligible for High-dose Chemotherapy Followed by Autotransplantation
The Purpose of this study is to evaluate the efficacy and the safety of R-GEMOX in refractory/relapsed patients with CD20-positive large B-cell lymphoma who are not eligible for autologous transplantation.
This is a multicentric, open-label, non-randomized clinical study, evaluating the efficacy
and the safety of R-GEMOX in refractory/relapsed patients aged from 18 to 75 years with
CD20-positive large B-cell lymphoma non eligible for autologous transplantation.
It is anticipated that 50 subjects will be enrolled over 4 years (from April 2003/January
2007), but inclusion could stop earlier according to the analysis performed every 5 patients
(based on triangular test).
The duration of the treatment period is approximately 16 weeks and patients are followed
until death.
The total duration of the study is expected to be 3 years.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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