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
until death.
The total duration of the study is expected to be 3 years.
Interventional
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
No
Corinne Haioun, MD
Study Chair
Hôpital Henri Mondor, Créteil, France
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
R-GEMOX
NCT00169195
April 2003
May 2010
Name | Location |
---|