HD ADVANCED DISEASE MedDRA version: 9.1 Level: HLGT Classification code 10025319 Term: Lymphomas Hodgkin's disease
Conditions
Interventions
Trade Name: ADRIBLASTINA
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Doxorubicin
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Concentration number:
Sponsors
AZIENDA OSPEDALIERA "S. CROCE E CARLE"
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 3 YEARS PFS;Secondary Objective: 3 YEARS EFS;Primary end point(s): 3 YEARS PFS | — |
Countries
Italy
Outcome results
None listed