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Treatment of Disseminated High Grade Lymphoma

NCT ID: NCT00536393

Last Updated: 2007-11-01

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/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-10-31

Study Completion Date

2004-10-31

Brief Summary

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Interest of the use of pegylated liposomal doxorubicin (caélyx)

Detailed Description

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R CHOP is a good standard in the treatment of diffuse high grade lymphoma. Howeverin elderly patients it is often toxic, specially with haematologic and cardiac toxicities.

Conditions

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Lymphoma

Keywords

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diffuse larg cells lymphoma chemotherapy toxicity diffuse high grade lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Doxorubicine

CHOP 8 courses every 21 days

Group Type ACTIVE_COMPARATOR

Doxorubicin

Intervention Type DRUG

Doxorubicine pegylated

CLOP 8 courses every 21 days

Group Type EXPERIMENTAL

Doxorubicin pegylated

Intervention Type DRUG

Interventions

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Doxorubicin

Intervention Type DRUG

Doxorubicin pegylated

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* high grade lymphoma
* disseminated
* \> 60 years old and \< 75
* informed consent signed
* cardiac state compatible with antracyclin
* ECOG \</= 2

Exclusion Criteria

* patients \> 75 years old
* Cardiac insufficiency
Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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French Innovative Leukemia Organisation

OTHER

Sponsor Role lead

Principal Investigators

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Guillaume CARTRON, Dr

Role: PRINCIPAL_INVESTIGATOR

French Innovative Leukemia Organisation

Locations

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Clinique Victor Hugo

Le Mans, , France

Site Status

Countries

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France

Other Identifiers

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GOELAMS 0804

Identifier Type: -

Identifier Source: org_study_id