NCT00443677

Brief Summary

The purpose of this study is to compare the toxicities of the COPPEBVCAD vs BEACOPP vs ABVD regimens.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
307

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2000

Longer than P75 for phase_3

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

April 1, 2000

Completed
6.9 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

March 20, 2009

Status Verified

March 1, 2009

First QC Date

March 5, 2007

Last Update Submit

March 19, 2009

Conditions

Advanced Hodgkin Disease

Outcome Measures

Primary Outcomes (1)

  • To compare the toxicity of the COPPEBVCAD vs BEACOPP vs ABVD regimens

Secondary Outcomes (1)

  • To compare the results in terms of response, failure free survival and relapse free survival of the three regimens

Study Arms (3)

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

COPPEBVCAD vs BEACOPP vs ABVDDRUG
abvdbeacoppcoppebvcad

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • HIV positivity
  • Large cell, anaplastic, CD30+ lymphoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Oncologico Modenese

Modena, 41100, Italy

Location

Study Officials

  • Paolo Gobbi, MD

    GISL

    PRINCIPAL INVESTIGATOR

  • Emilio Iannitto, MD

    GISL

    PRINCIPAL INVESTIGATOR

  • Giuseppe Polimeno, MD

    GISL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 5, 2007

First Posted

March 6, 2007

Study Start

April 1, 2000

Study Completion

June 1, 2007

Last Updated

March 20, 2009

Record last verified: 2009-03

Locations

IT(1)