GEMCITABINE-OXALIPLATINE PLUS RITUXIMAB (R-GEMOX) IN REFRACTORY/RELAPSED PATIENTS WITH CD20 POSITIVE DIFFUSE LARGE B-CELL LYMPHOMA, NON ELIGIBLE FOR HIGH-DOSE CHEMOTHERAPY FOLLOWED BY AUTOTRANSPLANTATION - R-GEMOX
- Conditions
- Refractory/relapsed patients with CD 20 positive large B-cell lymphoma
- Registration Number
- EUCTR2005-002344-26-BE
- Lead Sponsor
- GELA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
-Patient diagnosed with histologically or cytologically proven, CD20+, Diffuse Large B-cell Lymphoma
- Relapsed after first or second CR, PR or less than PR for first-line treatment for the rituximab-naïve patients OR relapsed after first or second CR with a minimum delay of 12 months between the last rituximab infusion and the inclusion for rituximab-experienced patients
- aged 18-75 years
- Not eligible for autologous transplantation
- Previously treated with chemotherapy containing anthracyclin, 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 enrollement
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- Burkitt's, mantle cell, T-cell lymphomas
- CD20-negative lymphoma
- HIV or HBV related disease
- Central nervous system or meningeal involvement by the lymphoma
- Not previously treated with anthracyclin-containing regimens
- Any radiotherapy during the four weeks before inclusion
- 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, poor hepatic function unless these abnormalities are related to the lymphoma
- Poor bone marrow reserve as defined <1.5G/l or platelets<100G/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
- Pregnant or lactatingwoman
- Adult patient unable to give informed consent because of intellectual impairement.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy and the safety of R_GEMOX in refractory/relapsed patient with CD20 positive large B-cell lymphoma non eligible for autologous transplantation;Primary end point(s): Overall Response Rate (ORR) (Complete Response, CR; Unconfirmed Complete Response, CRu and Partial Response, PR) at the end of 4 cycles of R-GEMOX;Secondary Objective: Overall Response Rate (ORR) at the completion of the treatment (8 cycles of R-GEMOX)<br><br>Event Free Survival (EFS) at 2 years: events being death from any cause, relapsed for complete responders and unconfirmed complete responders, progression during and after treatment, institution a new treatment.<br><br>Safety of R-GEMOX in this patient population<br><br>Overall survival, Time of progression, Disease-free survival for CR
- Secondary Outcome Measures
Name Time Method