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

NCT ID: NCT00965289

Last Updated: 2009-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2009-06-30

Brief Summary

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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.

Detailed Description

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Superiority of HDT with autologous stem cell transplantation (ASCT) in the upfront treatment of poor-risk DLBCL remains an option for intermediate-high (IH) or high IPI young adults. We updated results of the prospective trial Goelams 074 to evaluate long-term efficacy and toxicity in 42 patients who underwent HDT with ASCT.

Conditions

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B-Cell Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HDT combined with rituximab before ASCT

The study treatment consisted on 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.

Group Type EXPERIMENTAL

Rituximab

Intervention Type DRUG

Rituximab infusion on day 1 dose: 375mg/m²

Interventions

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Rituximab

Rituximab infusion on day 1 dose: 375mg/m²

Intervention Type DRUG

Other Intervention Names

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Mabthera®

Eligibility Criteria

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Inclusion Criteria

* Age 18 to 60 y.o
* Aggressive Large B-Cell Lymphoma (CD20+)
* Ann Arbor stage III, IV
* IH or high adjusted IPI
* signed inform consent

Exclusion Criteria

* Age \< 18 ou \> 60 y.o
* other type of lymphoma
* serology VIH +
* other neoplasms apart from basal cell carcinoma or situ carcinoma
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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French Innovative Leukemia Organisation

OTHER

Sponsor Role collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role collaborator

Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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NANTES UNIVERSITY HOSPITAL /GOELAMS

Principal Investigators

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Noel MILPIED, PD MS

Role: PRINCIPAL_INVESTIGATOR

CHU NANTES/GOELAMS

Locations

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University Hospital

Nantes, , France

Site Status

Countries

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France

Other Identifiers

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GOELAMS 074

Identifier Type: -

Identifier Source: org_study_id

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