Treatment of Disseminated High Grade Lymphoma

French Innovative Leukemia Organisation

Status and phase: Completed; Phase 3; Phase 2

Conditions: Lymphoma

Treatments: Drug: Doxorubicin; Drug: Doxorubicin pegylated

Study type: Interventional

Funder types: Other

Identifiers

NCT00536393

GOELAMS 0804

Details and patient eligibility

About

Interest of the use of pegylated liposomal doxorubicin (caélyx)

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 60 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Doxorubicine

Active Comparator group

Description:

CHOP 8 courses every 21 days

Treatment:

Drug: Doxorubicin

Doxorubicine pegylated

Experimental group

Description:

CLOP 8 courses every 21 days

Treatment:

Drug: Doxorubicin pegylated