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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
246
Rituximab-HDS
Rituximab-CHOP
Clinica di Ematologia - Nuovo Ospedale Torrette
Ancona, Italy
U.O. Ematologia - Ospedali Riuniti di Bergamo
Bergamo, Italy
Event Free Survival
EFS was defined from the time of the study entry to any treatment failure including disease progression or discontinuation of treatment for any reason or date of the last follow-up visit
Time frame: 36 months from end of therapy
Complete Remission
Clinical response was assessed by complete restaging according to Cheson criteria. Cheson BD, Pfistner B, Juweid ME, et al: Revised response criteria for malignant lymphoma. J Clin Oncol 25:579-86, 2007
Time frame: Through therapy completion an average of 8 months
Disease Free Survival
DFS was defined from the time of documentation of CR to time to relapse or death as a result of lymphoma or acute toxicity of treatment or date of the last follow-up visit
Time frame: 36 months from end of therapy
Overall Survival
OS was defined from the time of the study entry to death as a result of any cause or date of the last follow-up visit
Time frame: 36 months from end of therapy
Toxicity
Percentage of participants with at least one reported episode of CTC grade III or IV toxic events
Time frame: Through therapy completion an average of 8 months
Efficacy of R-HDS Conditioning as Salvage Therapy in Patients Non-responders After Four Cycles of R-CHOP 14
Time frame: Through completion of salvage therapy
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Divisione di Ematologia - Ospedale Centrale di Bolzano
Bolzano, Italy
CTMO - Ematologia - Ospedale "R. Binaghi"
Cagliari, Italy
Divisione di Ematologia - Ospedale Ferrarotto
Catania, Italy
S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle
Cuneo, Italy
Divisione Ematologia - Istituto S. Raffaele
Milan, Italy
Oncologia Medica - Istituto Nazionale dei Tumori
Milan, Italy
U.O. Ematologia - Istituto Nazionale dei Tumori
Milan, Italy
Divisione di Ematologia - Azienda Ospedaliera
Padua, Italy
...and 6 more locations