Rituximab, Gemcitabine and Oxaliplatin (R-GEMOX) for Refractory/Relapsed B-cell Lymphoma

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.