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
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
The total duration of the study is expected to be 3 years.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate (ORR) (complete response, [CR]; unconfirmed complete response, [CRu] and partial response, [PR])
end of 4 cycles of R-GEMOX
Corinne Haioun, MD
Hôpital Henri Mondor, Créteil, France
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)