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OpenTrials
Completed

NCT Number: NCT00536393

Treatment of Disseminated High Grade Lymphoma

Interest of the use of pegylated liposomal doxorubicin (caélyx)

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Key information

Conditions

Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Clinique Victor Hugo

Le Mans, 72015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doxorubicin

Drug

Doxorubicin pegylated

Drug

Primary outcomes

  1. hematologic toxicity

    Time frame: 6 months

Secondary outcomes

  1. response rate

    Time frame: 6 months

  2. EFS and OS

    Time frame: 6 months

  3. Cardiac toxicity

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

French Innovative Leukemia Organisation

Other

Registry information

Official study title

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

Important dates

Study start
2000
Study completion
2004
First posted
Sep 27, 2007
Registry last updated
Nov 1, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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