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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 the study is expected to be 3 years.

Official Title
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Gemcitabine-oxaliplatin Plus Rituximab (R-GEMOX) in Refractory/Relapsed Patients With CD 20 Positive Diffuse Large B-cell Lymphoma, Non Eligible for High-dose Chemotherapy Followed by Autotransplantation

Conditions
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Diffuse Large Cell Lymphoma

Intervention / Treatment
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* Drug: Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: R-GEMOX<br>Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX) | Drug: Gemcitabine-Oxaliplatin plus Rituximab (R-GEMOX)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (ORR) (complete response, [CR]; unconfirmed complete response, [CRu] and partial response, [PR]) | 4 cycles of R-GEMOX | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (ORR) (complete response, [CR]; unconfirmed complete response, [CRu] and partial response, [PR]) | completion of the treatment | 16 weeks | 
| Event free survival (EFS) |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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B-cell lymphoma, Salvage Therapy, rituximab, oxaliplatine, gemcitabine