Treatment of Disseminated High Grade Lymphoma

October 31, 2007 updated by: French Innovative Leukemia Organisation

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

Interest of the use of pegylated liposomal doxorubicin (caélyx)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Le Mans, France, 72015
        • Clinique Victor Hugo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Doxorubicine
CHOP 8 courses every 21 days
Drug: Doxorubicin
Experimental: Doxorubicine pegylated
CLOP 8 courses every 21 days
Drug: Doxorubicin pegylated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
hematologic toxicity
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
response rate
Time Frame: 6 months
6 months
EFS and OS
Time Frame: 6 months
6 months
Cardiac toxicity
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French Innovative Leukemia Organisation

Investigators

  • Principal Investigator: Guillaume CARTRON, Dr, French Innovative Leukemia Organisation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2000

Study Completion (Actual)

October 1, 2004

Study Registration Dates

First Submitted

September 26, 2007

First Submitted That Met QC Criteria

September 26, 2007

First Posted (Estimate)

September 27, 2007

Study Record Updates

Last Update Posted (Estimate)

November 1, 2007

Last Update Submitted That Met QC Criteria

October 31, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOELAMS 0804

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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