Brentuximab Vedotin as Consolidation Treatment in Patients With Stage I/II HL and PET Positivity After 2 Cycles of ABVD

Exclusion Criteria

• •1. Patients with dementia or altered mental status that would preclude compliance with drug delivery
• •2. Women who are pregnant or breastfeeding
• •3. Patients with symptomatic pulmonary disease
• •4. Patients with known history of any of the following cardiovascular conditions:
• •* Myocardial infarction within 2 years of inclusion
• •* 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
• •* Recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction \<50%
• •5. Any history of cancer or cancer treatment during the last 3 years with the exception of non-melanoma skin cancer or stage 0 (in situ) carcinoma of any type if they have undergone complete resection
• •6. Uncontrolled infectious disease, including active Hepatitis B Virus (HBV) infection defined by either detection of Hepatitis B surface (HBs) Antigen or presence of Hepatitis B core (HBc) antibody without detectable anti HBs antibody
• •7. Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics at the time of inclusion and planned to be still on going within 2 weeks prior to first study drug dose
• •8. Known Human Immunodeficiency Virus (HIV), known or suspected hepatitis C Virus (HCV) or human T-cell lymphotrophic virus (HTLV) serology positivity
• •9. Patients who have been treated previously with any anti-CD30 antibody
• •10. Known hypersensitivity to any excipients contained in the brentuximab vedotin formulation
• •11. Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of Progressive Multifocal Leukoencephalopathy (PML)
• •12. Any sensory or motor peripheral neuropathy greater than or equal to Grade 2
• •13. Patients that have not completed any prior treatment chemotherapy and/or other investigational agents within at least 5 half-lives of last dose of that prior treatment