Rituximab, Gemcitabine and Oxaliplatin (R-GEMOX) for Refractory/Relapsed B-cell Lymphoma
Diffuse Large Cell Lymphoma
About this trial
This is an interventional treatment trial for Diffuse Large Cell Lymphoma focused on measuring B-cell lymphoma, Salvage Therapy, rituximab, oxaliplatine, gemcitabine
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with histologically or cytologically proven, CD 20+, diffuse large B-cell lymphoma, Relapse after first or second CR, PR or less than PR to first-line treatment for the rituximab-naïve patients, OR relapse after first or second CR with a minimum delay of 12 months between the last rituximab infusion and the inclusion for the rituximab-experienced patients Aged 18 - 75 years Not eligible for autologous transplantation Previously treated with chemotherapy containing anthracycline, with or without rituximab ECOG performance status 0 to 2 With a minimum life expectancy of 3 months Having signed informed consent form prior to enrollment Exclusion Criteria: Burkitt's, mantle cell, T-cell lymphomas CD 20-negative lymphoma HIV or HBV related disease Central nervous system or meningeal involvement by the lymphoma Not previously treated with anthracycline-containing regimens Contraindication to any drug contained in the R-GEMOX chemotherapy regimen Any serious active disease or co-morbid medical condition (according to the investigator's decision), Poor renal function (creatinine level > 150micromol/l), poor hepatic function (total bilirubin level > 30mmol/l, transaminases > 2.5 maximum normal level) unless these abnormalities are related to the lymphoma Poor bone marrow reserve as defined by neutrophils < 1.5 G/l or platelets < 100 G/l, unless related to bone marrow infiltration Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study Any radiotherapy during the four weeks before inclusion Pregnant or lactating woman Adult patient unable to give informed consent because of intellectual impairment.
Sites / Locations
- 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
Arms of the Study
Arm 1
Experimental
R-GEMOX
Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX)