The purpose of this trial was to evaluate efficacy and safety of adding Rituximab to dose-dense and High-Dose Chemotherapy (HDC) with Autologous Stem Cell Transplantation (ASCT) as first line treatment in young patients with DLBCL at Intermediate-High and High risk aaIPI score
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
94
375 mg/m2 on day 1
110 mg/m2 on day 3
1200 mg/m2 on day 3
Az. Ospedaliera SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
Ospedale Regionale, Divisione di Oncologia,
Aosta, Italy
Azienda Ospedaliera Ospedale Policlinico Consorziale
Bari, Italy
Failure-free survival
Time frame: Three years
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1.4 mg/m2 (maximum 2 mg) on day 3
40 mg/m2 from day 1 to 5
(G-CSF 5 μg/Kg/day) from day 5 to day 11
8 mg/m2 for 3-day
2 g/m2/12 hours for six doses in 3-hour infusion
4 mg/m2/12 hours before ARA-C administration
300 mg/m2 on day -7
100 mg/m2/12 hours
140 mg/m2 on day -2
Involved Field Radiotherapy (IF-RT)
ASCT
Osp. degli Infermi
Biella, Italy
Spedali Civili
Brescia, Italy
Centro Trapianti Midollo Osseo, P.O. Businco
Cagliari, Italy
Ospedale S. Gerardo
Monza, Italy
Osp. maggiore della Carità
Novara, Italy
Università degli Studi Policlinico Monteluce
Perugia, Italy
Divisione di Medicina, Ospedale Generale E. Agnelli, Pinerolo
Torino, Italy
...and 4 more locations