Treatment of Disseminated High Grade Lymphoma

Phase III Study of Treatment of Disseminated and Agressive Lymphoma R CHOP Versus R CLOP( With Liposomal Doxorubicin)

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00536393

Enrollment

100

Registered

2007-09-27

Start date

2000-10-31

Completion date

2004-10-31

Last updated

2007-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Keywords

diffuse larg cells lymphoma, chemotherapy, toxicity, diffuse high grade lymphoma

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.

Interventions

DRUGDoxorubicin

DRUGDoxorubicin pegylated

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
hematologic toxicity	6 months

Secondary

Measure	Time frame
response rate	6 months
EFS and OS	6 months
Cardiac toxicity	6 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026