Dose-dense ABVD as first line therapy in early stage unfavorable Hodgkin’s Lymphoma: a phase II, prospective, multi-center study

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 86

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 < 2.5 x ULN, AST/SGOT and/or ALT/SGPT = 2.5 x upper limit of normal (ULN) or = 5.0 x ULN if the transaminase elevation is due to disease involvement, serum creatinine < 2.5 x ULN)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 81
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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