Rituximab in Addition to Chemotherapy With Autologous Stem Cell Transplantation as Treatment Diffuse Large B-Cell Lymphoma

PHASE2CompletedINTERVENTIONAL
Enrollment

94

Participants

Timeline

Start Date

June 30, 2002

Study Completion Date

September 30, 2006

Conditions
Diffuse Large B-Cell LymphomaPOOR PROGNOSIS
Interventions
DRUG

Rituximab

375 mg/m2 on day 1

DRUG

Epirubicin

110 mg/m2 on day 3

DRUG

Cyclophosphamide

1200 mg/m2 on day 3

DRUG

Vincristine

1.4 mg/m2 (maximum 2 mg) on day 3

DRUG

Prednisone

40 mg/m2 from day 1 to 5

DRUG

Granulocyte-colony-stimulating factor

(G-CSF 5 μg/Kg/day) from day 5 to day 11

DRUG

Mitoxantrone

8 mg/m2 for 3-day

DRUG

Cytarabine ARA-C

2 g/m2/12 hours for six doses in 3-hour infusion

DRUG

Dexamethasone

4 mg/m2/12 hours before ARA-C administration

DRUG

Carmustine BCNU

300 mg/m2 on day -7

DRUG

Etoposide

100 mg/m2/12 hours

DRUG

Melphalan

140 mg/m2 on day -2

RADIATION

Radiotherapy

Involved Field Radiotherapy (IF-RT)

PROCEDURE

PBSC reinfusion

ASCT

Trial Locations (14)

Unknown

Az. Ospedaliera SS. Antonio e Biagio e Cesare Arrigo, Alessandria

Ospedale Regionale, Divisione di Oncologia,, Aosta

Azienda Ospedaliera Ospedale Policlinico Consorziale, Bari

Osp. degli Infermi, Biella

Spedali Civili, Brescia

Centro Trapianti Midollo Osseo, P.O. Businco, Cagliari

Ospedale S. Gerardo, Monza

Osp. maggiore della Carità, Novara

Università degli Studi Policlinico Monteluce, Perugia

Divisione di Medicina, Ospedale Generale E. Agnelli, Pinerolo, Torino

Istituto per la Ricerca e la Cura del Cancro, Candiolo, Torino

"Osp. S. Giovanni Battista Molinette", Torino

Ospedale di Chivasso e Ivrea, Torino

Stabilimento Ospedaliero Ciriè -, Torino

All Listed Sponsors
lead

Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie

OTHER

NCT00556127 - Rituximab in Addition to Chemotherapy With Autologous Stem Cell Transplantation as Treatment Diffuse Large B-Cell Lymphoma | Biotech Hunter | Biotech Hunter