Treatment of Advanced Hodgkin's Disease (Stages IIB-III-IV) | NCT00443677

Studies
Treatment of Advanced Hodgkin's Disease (Stages IIB-III-IV)

NCT00443677

Sponsor

Gruppo Italiano Studio Linfomi

Status

Completed

Last Update Posted

Mar 20, 2009Estimated

Enrollment

307Actual

Phase

Phase 3

Conditions

Advanced Hodgkin Disease

Interventions

COPPEBVCAD vs BEACOPP vs ABVD

Countries

Italy

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

Mar 2009

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

Apr 2000

Primary Completion Date

Not provided

Completion Date

Jun 2007Actual

First Submitted Date

Mar 5, 2007

First Submission Date that Met QC Criteria

Mar 5, 2007

First Posted Date

Mar 6, 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

Mar 19, 2009

Last Update Posted Date

Mar 20, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

307Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
abvd	Active Comparator	Drug: COPPEBVCAD vs BEACOPP vs ABVD
beacopp	Experimental	Drug: COPPEBVCAD vs BEACOPP vs ABVD
coppebvcad	Experimental	Drug: COPPEBVCAD vs BEACOPP vs ABVD

Interventions

Name	Type	Description	Arm Group Labels	Other Names
COPPEBVCAD vs BEACOPP vs ABVD	Drug		abvd beacopp coppebvcad

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To compare the toxicity of the COPPEBVCAD vs BEACOPP vs ABVD regimens

Secondary Outcomes

Measure	Description	Time Frame
To compare the results in terms of response, failure free survival and relapse free survival of the three regimens

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed diagnosis of Hodgkin disease
Clinical stage IIB, III, IV
No prior treatment for Hodgkin disease or other malignancy
Age 18-65 year
Good cardiac, pulmunar, renal and hepatic function
Performance status 0-3 (Karnofsky 100- 40)
Written Informed Consent

Exclusion Criteria:

HIV positivity
Large cell, anaplastic, CD30+ lymphoma

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 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
Paolo Gobbi, MD	GISL	Principal Investigator
Emilio Iannitto, MD	GISL	Principal Investigator
Giuseppe Polimeno, MD	GISL	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centro Oncologico Modenese		Modena		41100	Italy