Short Term Intensified Chemo-immunotherapy in HIV-positive Patients With Burkitt Lymphoma

PHASE2CompletedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

April 30, 2013

Study Completion Date

August 31, 2015

Conditions
HIVBurkitt's Lymphoma
Interventions
DRUG

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"

DRUG

Consolidation Phase (on day +50)

"* dd 1-2: cytarabine twice a day~* dd 3 and 11: rituximab~* dd 11-13: leukapheresis for PBPC collection."

DRUG

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)."

DRUG

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

RADIATION

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

Trial Locations (8)

Unknown

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

All Listed Sponsors
lead

Andres J. M. Ferreri

OTHER

NCT01516593 - Short Term Intensified Chemo-immunotherapy in HIV-positive Patients With Burkitt Lymphoma | Biotech Hunter | Biotech Hunter