HODGKIN LIMPHOMA MedDRA version: 14.1 Level: SOC Classification code 10005329 Term: Blood and lymphatic system disorders System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Trade Name: DOXORUBICINA BAXTER*EV 20FL50M
Pharmaceutical Form: Solution for injection
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: mg
Sponsors
FONDAZIONE ITALIANA LINFOMI ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age 18-70 years • Histologically confirmed HL stage I, II unfavorable according to EORTC criteria, with exclusion of stage II B bulky. • Previously untreated • ECOG performance status 0 - 2 • Staging with FDG-PET • Written informed consent • Adequate liver and renal function (total serum bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: • Concomitant cardiac, pulmonary, neurologic, psychiatric or metabolic severe disease. • Uncontrolled diabetes mellitus (with fasting glucose levels above 200 mg/dl). • Other prior malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast or other cancer from which the patient has been disease-free for = 3 years • Patients with a known history of HIV seropositivity • Active HCV infection ( PCR + ; AST> 1.5-2x UN) • Woman who is pregnant or breast feeding. Fertile patients not willing to use effective contraception during the study and 3 months after the end of treatment. Women of childbearing potential (WOCBP) are defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months. Negative pregnancy test at baseline is required (serum???HCG). • Male patient whose sexual partner(s) are WOCBP who are not willing to use a effective contraception during the study and 3 months after the end of treatment • Nodular lymphocyte prevalence histological subtype
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Feasibility and Activity;Secondary Objective: • Comparison of PET interpretation criteria (IHP, Deauville) in predicting outcome • Efficacy of the scheme • Acute and late hematological and extra-hematological toxicities;Primary end point(s): • Proportion of patient with a dose intensity reduction (lower than 85% of planned dose) • Proportion of FDG-PET negativity after two cycle of dd-ABVD;Timepoint(s) of evaluation of this end point: 3 mounths | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Overall accuracy and Predictive Value of each interim PET interpretation criteria after a minimum follow-up of three years • PFS and OS • Proportion of early and late toxicities (G3/4 acute toxicities, secondary malignancies, cardiovascular and pulmonary events, infertility);Timepoint(s) of evaluation of this end point: 3 years | — |
Countries
Italy
Contacts
Public ContactSegreteria Protocolli Clinici FIL
Fondazione Italiana Linfomi Onlus
Outcome results
None listed