Status:
COMPLETED
Rituximab, Gemcitabine and Oxaliplatin (R-GEMOX) for Refractory/Relapsed B-cell Lymphoma
Lead Sponsor:
Lymphoma Study Association
Collaborating Sponsors:
Hoffmann-La Roche
Sanofi-Synthelabo
Conditions:
Diffuse Large Cell Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 transplanta...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00169195
Start Date
April 1 2003
End Date
November 1 2012
Last Update
September 2 2015
Active Locations (8)
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1
Hôpital Henri Mondor
Créteil, France
2
Service d'Hématologie Clinique - CHU Le Bocage
Dijon, France
3
Service des Maladies du Sang - CHRU de Lille
Lille, France
4
Centre Léon Bérard
Lyon, France