PHASE II MULTICENTRE CLINICAL STUDY WITH EARLY TREATMENT INTENSIFICATION IN PTS WITH HIGH-RISK HODGKIN LYMPHOMA, IDENTIFIED AS FDG-PET SCAN POSITIVE AFTER TWO CONVENTIONAL ABVD COURSES - HD 0607

• Conditions: HD ADVANCED DISEASE; MedDRA version: 9.1Level: HLGTClassification code 10025319Term: Lymphomas Hodgkin's disease

• Registration Number: EUCTR2007-007168-94-IT
• Lead Sponsor: AZIENDA OSPEDALIERA S. CROCE E CARLE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

AGE BETWEEN 18 AND 60 YEARS HISTOLOGICALLY PROVEN DIAGNOSIS OF HD ACCORDING TO THE WHO CLASSIFICATION NOT PREVIOUSLY TREATED WRITTEN INFORMED CONSENT
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

POSITIVE SEROLOGIC MARKERS OF HIV,HBV, HCV AND PRESENCE OF VIRAL DNA/RNA COPIES IN THE PERIPHERAL BLOOD IMPAIRED LIVER,RENAL,LUNG,MYOCARDIAL FUNCTION DIABETES MELLITUS REQUIRING INSULINE THERAPY PREGNANCY OR LACTATION PSYCHIATRIC DISEASE SEVERELY IMPAIRING THE COMPLIANCE OF THE PATIENT TO PARTECIPATE TO THE STUDY AND TO GIVE AN INFORMED CONSENT ANY ACTIVE, UNCONTROLLED INFECTIONS AND CONCOMITANT NEOPLASTIC DISEASE

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 3 YEARS PFS;Secondary Objective: 3 YEARS EFS;Primary end point(s): 3 YEARS PFS