CD 20 positive diffuse large B cell lymphoma
Conditions
Interventions
Trade Name: Mabthera
Product Name: Mabthera
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Rituximab
Concentration unit: mg/m2 milligram(s)/square meter
Concentration
Sponsors
GELA-Recherche Clinique
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with CD20 positive diffuse large B-cell lymphoma.Disease must be histologically proven in case ofrelapse or partial response Aged 18-65 Eligible for transplanatation ECOG performance =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Burkitt, mantle-cell and T-cell lymphoma CD20 negative diffuse large cell lymphoma Not previouly treated with anthracycline-containing regimens Prior transplantation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the induction therapy is to evaluate the efficacy and safety of ICE plus Rituximab (R-ICE) in comparison with DHAP plus Rituximab (R-DHAP) in previously treated patients with CD20 positive diffuse large B cell lymphoma eligibale for autologous transplantation The objective of the maintenance therapy is to evaluate the efficacy and safety of Rituximab maintenance therapy after transplantation;Secondary Objective: ;Primary end point(s): Induction therapy- overall response rate (CR and PR) after 3 cycles of ICE + R in comparison to DHAP + R, adjusted to successful mobilization of stem cells in patients aged 18-65 with previously treated diffuse large B cell lymphoma Maintenance therapy- event free survival at 2 years after autotransplant with to without maintenance therapy with Rituximab. Events are defined as death from any cause, relapse for complete responders and unconfirmed complete responders, progression during or after treatment for partial responders. | — |
Countries
Ireland
Outcome results
None listed