NCT00536393

Brief Summary

Interest of the use of pegylated liposomal doxorubicin (caélyx)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_2 lymphoma

Timeline
Completed

Started Oct 2000

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2000

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 27, 2007

Completed
Last Updated

November 1, 2007

Status Verified

September 1, 2007

First QC Date

September 26, 2007

Last Update Submit

October 31, 2007

Conditions

Lymphoma

Keywords

diffuse larg cells lymphomachemotherapytoxicitydiffuse high grade lymphoma

Outcome Measures

Primary Outcomes (1)

  • hematologic toxicity

    6 months

Secondary Outcomes (3)

  • response rate

    6 months

  • EFS and OS

    6 months

  • Cardiac toxicity

    6 months

Study Arms (2)

Doxorubicine

ACTIVE COMPARATOR

CHOP 8 courses every 21 days

Drug: Doxorubicin

Doxorubicine pegylated

EXPERIMENTAL

CLOP 8 courses every 21 days

Drug: Doxorubicin pegylated

Interventions

DoxorubicinDRUG
Doxorubicine
Doxorubicin pegylatedDRUG
Doxorubicine pegylated

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • patients \> 75 years old
  • Cardiac insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Victor Hugo

Le Mans, 72015, France

Location

MeSH Terms

Conditions

Lymphoma

Interventions

Doxorubicin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Guillaume CARTRON, Dr

    French Innovative Leukemia Organisation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 26, 2007

First Posted

September 27, 2007

Study Start

October 1, 2000

Study Completion

October 1, 2004

Last Updated

November 1, 2007

Record last verified: 2007-09

Locations

FR(1)