19
Participants
Start Date
November 30, 2011
Primary Completion Date
April 30, 2013
Study Completion Date
August 31, 2015
Induction Phase
"* dd -2 to 1: Methylprednisolone~* dd 0-1, Cyclophosphamide, associated on day 0 with Vincristine~* dd 2, Rituximab~* dd 7, Methotrexate~* dd 14, Rituximab~* dd 15, Etoposide~* dd 21, Methotrexate~* dd 29, Rituximab and Doxorubicin~* dd 36, Rituximab and VCR~At the end of this induction phase, subsequent treatment will be performed according to the objective response:~1. pts in CR: consolidation phase followed by bulky site irradiation~2. pts in PR: consolidation phase followed by BEAM conditioning regimen supported by ASCT and bulky irradiation~3. pts with SD after induction or PD during or after induction: intensification phase followed by BEAM conditioning regimen supported by ASCT and bulky irradiation"
Consolidation Phase (on day +50)
"* dd 1-2: cytarabine twice a day~* dd 3 and 11: rituximab~* dd 11-13: leukapheresis for PBPC collection."
Intensification phase
"1. One or two courses of R-IVAC or R-ICE chemoimmunotherapy regimen, every three weeks as debulking.~2. CTX (dd 1) associated with rituximab on dd 3 and 10, followed by PBPC collection (dd 11-13);~3. AraC every 12 hours for four days (dd -5 to -2) supported by reinfusion of CD34+ cells (dd 0), rituximab infusion (dd -1 and +11) and second in-vivo purged PBPC collection (if needed)."
BEAM conditioning
BCNU on dd 1; VP-16 every 12 hours on dd 2-5 and araC every 12 hours on dd 2-5; melphalan on dd 6, followed by the reinfusion of CD34+ cells
Consolidation radiotherapy
At the end of the whole program, patients will be evaluated for involved-field irradiation with 6-10 MeV photons and a dose of 36 Gy (2 Gy/d, five fractions a week). Three subgroups of patients will be considered for radiotherapy
Oncologia Medica A - Centro di Riferimento Oncologico, Aviano (PN)
Ematologia - A.O. Spedali Civili, Brescia
Dip. Oncoematologia - Fondazione Centro San Raffaele del Monte Tabor, Milan
S.C. Oncologia Medica - Ospedale San Paolo, Milan
S.C. Oncologia Medica 3 - IRCCS Istituto Nazionale Tumori (INT), Milan
U.O.C. Immunodeficienze virali - I.N.M.I. L. Spallanzani, Roma
S.C. Oncoematologia - A.O. Santa Maria, Terni
U.O. Ematologia 2 - Ospedale San Giovanni Battista, Torino
Andres J. M. Ferreri
OTHER