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

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lymphoma Study Association
• Collaborators: Eli Lilly and Company; Hoffmann-La Roche; Sanofi-Synthelabo
• Treatments: Gemcitabine; Oxaliplatin; Rituximab

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.