Refractory/relapsed patients with CD 20 positive large B-cell lymphoma
Conditions
Interventions
Trade Name: MABTHERA 100mg
Product Name: Mabthera
Product Code: R045 2994
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Rituximab
CAS Number: 174722-31-7
Concentratio
Sponsors
GELA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) 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. Safety of R-GEMOX in this patient population Overall survival, Time of progression, Disease-free survival for CR | — |
Countries
Belgium
Outcome results
None listed