A Phase II Study of IGEV +/- Bortezomib Before Hign Dose Consolidation in Relapsed/Refractory Hodgkin's Lymphoma

Inclusion criteria

• Diagnosis of Hodgkin's lymphoma failing or relapsing after first-line chemotherapy (MOPP/AVBD , MOPP/EBV/CAD and analogs are considered one line)
• Age >18 and <65 years
• Signed informed consent
• If female, patient is either postmenopausal or surgically sterilized or willing to use an acceptable method of birth control
• If male, patient agrees to use an acceptable barrier method for contraception
• ECOG performance status <2
• Platelet count >100.000/mmc
• Hemoglobin >7.5 g/dL
• Absolute neutrophil count (ANC) >1.500/mmc
• Serum calcium <3.5 mmol/L (<14 mg/dL)
• AST/ALT: <2.5 x the ULN
• Total bilirubin: <1.5 x the ULN

Exclusion criteria

• Previous treatment with velcade
• Nitrosoureas within 6 weeks or any other chemotherapy within 3 weeks before enrollment
• Immunotherapy or antibody therapy within 4 weeks before enrollment
• Experimental drug or medical device within 4 weeks before start of treatment
• Major surgery within 4 weeks before enrollment
• History of allergic reaction attributable to compounds containing boron or mannitol or any of the drugs in the IGEV regimen
• Peripheral neuropathy of NCI CTCAE Grade 2 or higher
• Myocardial infarction within 6 months of enrollment or NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
• History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances including diabetes mellitus
• Need for therapy with concomitant CYP 3A4 inhibitors or inducers
• HIV-positive, if known
• Hepatitis B surface antigen-positive or active hepatitis C infection, if known
• Active systemic infection requiring treatment
• If female, pregnancy or breast-feeding.