MedTrace Logo

Targeted Intensification With ZBEAM and Autologous Stem Cell Transplantation in Patients With High-grade B-Cell Lymphoma

NCT00689169 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2018-03-07

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and the safety of a preparative regimen utilizing standard-dose Yttrium-90 Ibritumomab Tiuxetan (Zevalin) radioimmunotherapy combined with high-dose BEAM followed by ASCT after first line treatment in patients aged from 18 to 65 years with poor prognosis CD 20 Diffuse Large B-Cell lymphoma

Conditions

  • Lymphoma, Large Cell, Diffuse

Interventions

DRUG

ZBEAM (Zevalin, BCNU, Etoposide, Aracytine, Melphalan)

Zevalin 0.4 mCi/kg: D-14 BCNU 300 mg/m² : D-6 Etoposide 100 mg/m²/12h : D-6 D-5 D-4 D-3 Aracytine 200 mg/m²/12h : D-6 D-5 D-4 D-3 Melphalan 140 mg/m²: D-2

PROCEDURE

ASCT

ASCT : D0

DRUG

Rituximab

Rituximab 250 mg/m² :D-21 D-14

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Lymphoma Study Association

    lead OTHER

Principal Investigators

  • Christian Gisselbrecht, MD · Lymphoma Study Association

  • Christophe Fruchart, MD · Lymphoma Study Association

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2011-01-31
Completion
2014-01-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00689169 on ClinicalTrials.gov