Treatment of Disseminated High Grade Lymphoma - Full Text View

Treatment of Disseminated High Grade Lymphoma

This study has been completed.

Sponsored by:	Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Information provided by:	Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
ClinicalTrials.gov Identifier:	NCT00536393

Purpose

Interest of the use of pegylated liposomal doxorubicin (caélyx)

Condition	Intervention	Phase
Lymphoma	Drug: Doxorubicin Drug: Doxorubicin pegylated	Phase II Phase III

MedlinePlus related topics:

Lymphoma

Drug Information available for:

Doxorubicin Doxorubicin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS:

Primary Outcome Measures:

hematologic toxicity [ Time Frame: 6 months ]

Secondary Outcome Measures:

response rate [ Time Frame: 6 months ]
EFS and OS [ Time Frame: 6 months ]
Cardiac toxicity [ Time Frame: 6 months ]

Enrollment:	100
Study Start Date:	October 2000
Study Completion Date:	October 2004

Arms	Assigned Interventions
Doxorubicine: Active Comparator CHOP 8 courses every 21 days	Drug: Doxorubicin
Doxorubicine pegylated: Experimental CLOP 8 courses every 21 days	Drug: Doxorubicin pegylated

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.

Eligibility

Ages Eligible for Study:	60 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536393

Locations


France
	Clinique Victor Hugo
	LE MANS, France, 72015

Sponsors and Collaborators

Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS

Investigators


Principal Investigator:	Guillaume CARTRON, Dr	Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS

More Information

Study ID Numbers:	GOELAMS 0804
First Received:	September 26, 2007
Last Updated:	October 31, 2007
ClinicalTrials.gov Identifier:	NCT00536393
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS:

diffuse larg cells lymphoma

chemotherapy

toxicity

diffuse high grade lymphoma

Study placed in the following topic categories:

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphoma

Doxorubicin

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Immune System Diseases

Antineoplastic Agents

Therapeutic Uses

Antibiotics, Antineoplastic

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 24, 2008