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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Hôpital Henri Mondor
Créteil, France
Service d'Hématologie Clinique - CHU Le Bocage
Dijon, France
Service des Maladies du Sang - CHRU de Lille
Lille, France
Centre Léon Bérard
Lyon, France
Overall response rate (ORR) (complete response, [CR]; unconfirmed complete response, [CRu] and partial response, [PR])
4 cycles of R-GEMOX
Time frame: 8 weeks
Overall response rate (ORR) (complete response, [CR]; unconfirmed complete response, [CRu] and partial response, [PR])
completion of the treatment
Time frame: 16 weeks
Event free survival (EFS)
Time frame: 2 years
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Hôpital Saint Louis
Paris, France
Service D'Hématologie Adulte - Hôpital Necker
Paris, France
Centre Henri Becquerel
Rouen, France
CHRU de Nancy Brabois
Vandœuvre-lès-Nancy, France