MULTI-CENTRE, RANDOMISED, PHASE III TRIAL COMPARING HIGH DOSE SEQUENTIAL CHEMOTHERAPY hds WITH RITUXIMAB AND AUTOLOGOUS PERIPHERAL BLOOD PROGENITUR ALL TRANSPLANTION VERSUS 2- WEEKLY CHOP WITH RITUXIMAB AS FRONT LINE THERAPY OF HIGH RISK PATIENT WITH DIFFUSE LARGE B- CELL NON HODGKIN LYMPHOMA

INTERVENTION: Trade Name: ADRIBLASTINA*EV FL 50MG LIOF Pharmaceutical Form: Solution for injection INN or Proposed INN: Doxorubicin CAS Number: 25316‐40‐9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ Trade Name: VINCRISTINA PHARMACIA & U.*1MG Pharmaceutical Form: Solution for injection INN or Proposed INN: Vincristine CAS Number: 2068‐78‐2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1‐ Trade Name: ENDOXAN BAXTER*EV 1FL 1G Pharmaceutical Form: Powder for infusion* INN or Proposed INN: Cyclophosphamide CAS Number: 6055‐19‐2 Concentration unit: g gram(s) Concentration type: equal Concentration number: 1‐ Trade Name: MABTHERA*EV 1FL 50ML 500MG Pharmaceutical Form: Solution for infusion INN or Proposed INN: Rituximab CAS Number: 174722‐31‐7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500‐ Trade Name: DELTACORTENE FORTE*10CPR 25MG Pharmaceutical Form: Tablet INN or Proposed INN: Prednisone CAS Number: 53‐03‐2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25‐ Trade Name: GRANULOKINE 30*1FL 30MU 1ML Pharmaceutical Form: Solution for injection INN or Proposed INN: Filgrastim CAS Number: 121181‐53‐1 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 300‐ Trade Name: ADRIBLASTINA*EV FL 50MG LIOF Pharmaceutical Form: Solution for injection INN or Proposed INN: Doxorubicin CAS Number: 25316‐40‐9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ Trade Name: VINCRISTINA PHARMACIA & U.*1MG Pharmaceutical Form: Solution for injection INN or Proposed INN: Vincristine CAS Number: 2068‐78‐2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1‐ Trade Name: DELTACORTENE FORTE*10CPR 25MG Pharmaceutical Form: Tablet INN or Proposed INN: Prednisone CAS Number: 53‐03‐2 Concentration unit: mg milligram(s) Concentration type: equ CONDITION: ADULT PATIENTS WITH DIFFUSE LARGE B‐ CELL NON HODGKIN LYMPHOMA PRIMARY OUTCOME: Main Objective: Primary end point(s): Secondary Objective: INCLUSION CRITERIA: 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