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

Summary

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

Conditions

• Diffuse Large B-Cell Lymphoma
• POOR 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

Sponsors & Collaborators

• Gruppo Italiano Multiregionale per lo studio dei Linfomi e delle Leucemie

  lead OTHER

Principal Investigators

• Umberto Vitolo, MD · S.C. Ematologia II - OSP.S. GIOV.BATTISTA MOLINETTE - TORINO (TO) -

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2002-06-30

Completion

2006-09-30

Countries

• Italy

Study Locations