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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Event free survival
each 2 month during therapy administration and 1,3,6,9,12, 18, 24 months from end of therapy
Sergio Cortelazzo, MD
Divisione di Ematologia - Ospedale Centrale di Bolzano - 39100 Bolzano Italy
Italy: Ministry of Health