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High-dose Chemotherapy With Rituximab for Adults With Aggressive Large B-cell Lymphoma

NCT00965289 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2009-08-26

No results posted yet for this study

Summary

A prospective pilot trial was proposed to patients with DLBCL, with IH or high adjusted IPI, up to the age of 60 y.o. This program consisted of 2 courses of high-dose R-CHOP-like regimen, followed by a course of high-dose methotrexate with cytarabin. For patients who achieved at least a PR, ASCT started with a BEAM regimen.

Conditions

Interventions

DRUG

Rituximab

Rituximab infusion on day 1 dose: 375mg/m²

Sponsors & Collaborators

  • French Innovative Leukemia Organisation

    collaborator OTHER

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Noel MILPIED, PD MS · CHU NANTES/GOELAMS

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2002-04-30
Primary Completion
2003-05-31
Completion
2009-06-30

Countries

  • France

Study Locations

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Entities

Drugs
Diseases
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 NCT00965289 on ClinicalTrials.gov