R-ICE Versus R-DHAP in Patients Aged 18-65 With Relapse Diffuse Large B-cell Lymphoma

Summary

The primary objective of this study is to evaluate the efficacy and safety of induction therapy R-ICE in comparison to R-DHAP after 3 cycles adjusted to successful mobilization of stem cells in patients with previously treated diffuse large B-cell lymphoma CD20.

The goal is to detect a difference in mobilization adjusted response rate of 15% between R-ICE and R-DHAP.

The other objective is to evaluate the efficacy and safety of MabThera maintenance therapy after transplantation as measured by the event free survival.

The goal is to obtain a 15% increase of event free survival at 2 years.

Conditions

• Lymphoma, Large-Cell, Diffuse

Interventions

DRUG

Rituximab

375 mg/m² D-2/D1

DRUG

Etoposide

100 mg/m² D1-D2-D3

DRUG

Carboplatine

max 800mg D2

DRUG

Ifosfamide + Mesna

5 g/m² from D2 to D13

DRUG

Cisplatine

100 mg/m² from D1 to D13

DRUG

Cytosine Arabinoside

2000 mg/m²/12 h D2 D3

DRUG

Dexamethasone

40 mg From D1 to D4

PROCEDURE

Autologous Stem Cell Transplantation

DRUG

BCNU

300mg/m² on D-6

DRUG

Etoposide

200 mg/m² from D-6 to D-3

DRUG

Cytarabine

100 mg/m² from D-6 to D-3

DRUG

Melphalan

140 mg/m² on D-2

Sponsors & Collaborators

• Lymphoma Study Association

  lead OTHER

Principal Investigators

• Christian Gisselbrecht · Lymphoma Study Association

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2003-06-30

Primary Completion

2008-10-31

Completion

2008-10-31

FDA Drug

Yes

Countries

• United States
• Australia
• Belgium
• Czechia
• Finland
• Germany
• Israel
• Sweden
• Switzerland
• United Kingdom

Study Locations