Rituximab, Gemcitabine and Oxaliplatin (R-GEMOX) for Refractory/Relapsed B-cell Lymphoma
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.
Diffuse Large Cell Lymphoma
Drug: Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Overall response rate (ORR) (complete response, [CR]; unconfirmed complete response, [CRu] and partial response, [PR]) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]4 cycles of R-GEMOX
- Overall response rate (ORR) (complete response, [CR]; unconfirmed complete response, [CRu] and partial response, [PR]) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]completion of the treatment
- Event free survival (EFS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||April 2003|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX)
|Drug: Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00169195
|Hôpital Henri Mondor|
|Service d'Hématologie Clinique - CHU Le Bocage|
|Service des Maladies du Sang - CHRU de Lille|
|Centre Léon Bérard|
|Hôpital Saint Louis|
|Service D'Hématologie Adulte - Hôpital Necker|
|Centre Henri Becquerel|
|CHRU de Nancy Brabois|
|Vandoeuvre les Nancy, France|
|Study Chair:||Corinne Haioun, MD||Hôpital Henri Mondor, Créteil, France|
|Principal Investigator:||Corinne Haioun, MD||Hôpital henri Mondor, Créteil, France|