Conditions: Diffuse Large B-Cell Lymphoma
Keywords: DLBCL R-HDS R-CHOP14
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 246
Healthy volunteers: no

Brief summary:
Multicentric randomized phase III study comparing high doses of chemotherapy with Rituximab followed by auto-transplant HPC versus CHOP plus Rituximab as first line therapy in high risk patients with DLBCL Non-Hodgkin's lymphomas.

Detailed description:
Diffuse large B cells Non-Hodgkin's lymphomas represents one of the most frequent form of lymphoma. Its clinical development progresses rapidly and is characterized by a biphasic survival curve with patients in complete remission (which can be considered cured) and patients that relapse. This last group of subjects have only 25%-33% chance of long free disease survival if treated with a second line therapy with high dose chemotherapy plus autologous transplant of PBPC.

Therefore in order to achieve an improvement of the overall survival in patient with DLBCL, it is necessary to increase the number of complete remission after first line therapy.

The aim of R-HDS study, multicentre randomized phase III trial, is to evaluate and compare the efficacy and safety of an intensive conditioning regimen with high intensity chemo-immunotherapy (R-HDS) plus autologous transplantation versus CHOP conditioning regimen plus Rituximab in patients with unfavorable prognosis at diagnosis.

Arms:
arm 1: R-HDS : Rituximab supplemented high-dose (Cyclophosphamide,Ara-C, Methotrexate, Etoposide, Cis-Platin) sequential chemotherapy with autografting. arm 2: Rituximab-CHOP (cyclophosphamide/doxorubicin/vincristine/prednisone).

Interventions: intervention 1: Rituximab-HDS intervention 2: Rituximab-CHOP
Intervention descriptions: intervention 1: Rituximab-HDS intervention 2: Rituximab-CHOP

Protocol document: