Treatment of Disseminated High Grade Lymphoma | NCT00536393

Studies
Treatment of Disseminated High Grade Lymphoma

NCT00536393

Sponsor

French Innovative Leukemia Organisation

Status

Completed

Last Update Posted

Nov 1, 2007Estimated

Enrollment

100Actual

Phase

Phase 2Phase 3

Conditions

Lymphoma

Interventions

Doxorubicin
Doxorubicin pegylated

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2000

Primary Completion Date

Not provided

Completion Date

Oct 2004Actual

First Submitted Date

Sep 26, 2007

First Submission Date that Met QC Criteria

Sep 26, 2007

First Posted Date

Sep 27, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2007

Last Update Posted Date

Nov 1, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Doxorubicine	Active Comparator	CHOP 8 courses every 21 days	Drug: Doxorubicin
Doxorubicine pegylated	Experimental	CLOP 8 courses every 21 days	Drug: Doxorubicin pegylated

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Doxorubicin	Drug		Doxorubicine
Doxorubicin pegylated

Measure	Description	Time Frame
hematologic toxicity		6 months

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

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guillaume CARTRON, Dr	French Innovative Leukemia Organisation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinique Victor Hugo		Le Mans		72015	France

Condition Browse Module

MeSH Terms

ID	Term
D008223	Lymphoma

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004317	Doxorubicin

Ancestor Terms

ID	Term
D003630	Daunorubicin
D018943	Anthracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons

Browse Leaves

Not provided

Browse Branches

Not provided