Treatment of Disseminated High Grade Lymphoma

Phase 2

Completed

• Conditions: Lymphoma
• Interventions: Drug: Doxorubicin pegylated; Drug: Doxorubicin

• Registration Number: NCT00536393
• Lead Sponsor: French Innovative Leukemia Organisation

Brief Summary

Interest of the use of pegylated liposomal doxorubicin (caélyx)

Detailed Description

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.

Study Timeline

• Study Start: 2000-10
• Study Completion: 2004-10
• Status Verified: 2007-09
• Study First Submitted: 2007-09-26
• Study First Submitted QC: 2007-09-26
• Study First Posted: 2007-09-27
• Last Update Submitted: 2007-10-31
• Last Update Posted: 2007-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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Exclusion Criteria

• patients > 75 years old
• Cardiac insufficiency

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Doxorubicine pegylated	Doxorubicin pegylated	CLOP 8 courses every 21 days
Doxorubicine	Doxorubicin	CHOP 8 courses every 21 days

Primary Outcome Measures

Name	Time	Method
hematologic toxicity	6 months

Secondary Outcome Measures

Name	Time	Method
response rate	6 months
EFS and OS	6 months
Cardiac toxicity	6 months

Trial Locations

Locations (1)

Clinique Victor Hugo; 🇫🇷 Le Mans, France