Dose Dense Chemotherapy + Rituximab +/-Intensified High Dose Chemoimmunotherapy With Support of Peripheral Autologous Stem Cell in Diffuse Large B-Cell Lymphoma

Summary

The purpose of this study is to define an improvement in patients randomized in four different arms:

Arm 1: R-MegaCHOP14x4 + R-MAD + MAD + BEAM + ASCT; Arm 1BIS: R-CHOP14x4 + R-MAD + MAD + BEAM + ASCT; Arm 2: R-MegaCHOP14x4 + R-MegaCHOP14x2; Arm 2BIS: R-CHOP14x4 + R-CHOP14x4; Which are different in dose dense chemotherapy + Rituximab with or without intensified high dose chemoimmunotherapy and support of peripheral autologous stem cells.

Conditions

• Diffuse Large B-Cell Lymphoma
• IPI≥2

Interventions

DRUG

Rituximab

375 mg/m2 day 1

DRUG

Ciclofosfamide

1200 mg/m2 day 1

DRUG

Doxorubicina

70 mg/m2 day 1

DRUG

Vincristina

1,4 mg/m2 (max 2 mg) day 1

DRUG

Prednisone

100 mg day g 1-5

DRUG

Pegfilgrastim

6 mg day +1

DRUG

Mitoxantrone

8 mg/m2/days 1-3

DRUG

ARA-C

2000 mg/m2/12h day 1 - 3

DRUG

Lenograstim

5 μg/Kg/days +2

DRUG

BCNU

300 mg/m2 day -7

DRUG

ARA-C

200 mg/m2/12 days -6,-5,-4,-3

DRUG

VP-16

100 mg/m2/12h days -6,-5,-4,-3

PROCEDURE

ASCT

PBSC Reinfusion

DRUG

Ciclofosfamide

750 mg/m2 day 1

DRUG

Doxorubicina

50 mg/m2 day 1

DRUG

Vincristina

1,4 mg/m2 (max 2 mg) day 1

Sponsors & Collaborators

• Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte

  collaborator OTHER

• Fondazione Italiana Linfomi - ETS

  lead OTHER

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-01-31

Primary Completion

2011-06-30

Completion

2013-09-30

Countries

• Italy

Study Locations