Rituximab, Gemcitabine and Oxaliplatin (R-GEMOX) for Refractory/Relapsed B-cell Lymphoma
Recruitment status was Active, not recruiting
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:||Allocation: Non-Randomized
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: end of 4 cycles of R-GEMOX ] [ Designated as safety issue: No ]
- Overall response rate (ORR) (complete response, [CR]; unconfirmed complete response, [CRu] and partial response, [PR]) [ Time Frame: completion of the treatment ] [ Designated as safety issue: No ]
- Event free survival (EFS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||April 2003|
|Estimated Study Completion Date:||May 2010|
|Estimated Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
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.
|Hôpital Henri Mondor|
|Service d'Hématologie Clinique - CHU Le Bocage|
|Service des Maladies du Sang - CHRU de Lille|
|Centre Léon Bérard|
|Service D'Hématologie Adulte - Hôpital Necker|
|Hôpital Saint Louis|
|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|