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

Launched by LYMPHOMA STUDY ASSOCIATION · Sep 12, 2005

Keywords

ClinConnect Summary

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...

Gender

ALL

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.