Very Early PET-response Adapted Targeted Therapy for Advanced Hodgkin Lymphoma: a Single -Arm Phase II Study

Exclusion Criteria

• •Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of Progressive Multifocal Leukoencenphalopathy
• •Symptomatic neurologic disease compromising normal activities of daily living or requiring medications
• •Sensory or motor peripheral neuropathy greater than or equal to grade 2 according to CTCAE version 4.0
• •Any of the following cardiovascular conditions or values:
• •within 6 months before registration:
• •A left-ventricular ejection fraction \<50 percent (at registration)
• •New York Heart Association (NYHA) Class III or IV heart failure.
• •Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
• •symptomatic coronary heart disease (stable angina pectoris is allowed)
• •severe uncontrolled hypertension within 2 years before registration
• •Myocardial infarction
• •Patients with poorly controlled diabetes mellitus (HbA1c \> 7.5 percent or a fasting blood sugar \> 200 mg/dL).
• •Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to registration.
• •Known HIV infection, chronic active hepatitis C, HBV positivity (HBsAg + patients; HBsAg -/HBcAb+/HBV DNA+ patients).
• •Note: HBsAg-/HBV DNA - patients are eligible; patients who are seropositive due to vaccination are eligible
• •Concomitant or previous malignancies within the past 5 years with the exception of adequately treated carcinoma in situ of the cervix , nonmelanoma skin cancer.
• •Previous treatment with anti CD30 antibodies
• •Known hypersensitivity to any excipient contained in Brentuximab Vedotin formulation and other study drugs. Refer to Summary Product Characteristics for list of excipients.
• •Concurrent anti-cancer treatment or use of any investigational agent(s)