Study of OFATUMUMAB as Part of the Scheme of Reduced Intensity Conditioning in High Risk Non-Hodgkin Lymphoma B Patients

Exclusion Criteria

• •1. Refractory disease at the time of transplantation
• •2. Progressive disease at the time of transplantation.
• •3. ECOG≤2
• •4. Lymphoma associated with infection with human immunodeficiency virus (HIV).
• •5. Test positive for HIV.
• •6. Presence of anti-murine antibodies (HAMA) or (HACA).
• •7. Treatment with any marketed or experimental drug administered not in a period between 5 terminal half-lives of clearance of therapy or 4 weeks before enrollment
• •8. Participation in another interventional clinical trial.
• •9. Prior treatment with anti-CD20 monoclonal antibody or alemtuzumab within 3 months prior to start of therapy. This is generally required and may be excluded as applicable.
• •10. Hepatitis B positive serology
• •11. Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg.
• •12. Positive serology for hepatitis C (HC) defined as a positive test for HCAb.
• •13. Active liver or biliary disease (with exception of Gilbert's disease, cholelithiasis, metastases).
• •14. Other past or current malignancy.
• •15. Chronic infectious disease that requires ongoing treatment with systemic antibiotics, antifungal or antiviral drugs
• •16. History of cerebrovascular disease active in the last 6 months or event with significant symptoms or sequelae.
• •17. Clinically significant heart disease, such as unstable angina, acute myocardial infarction in the six months prior to inclusion, congestive heart failure (grades III-IV NYHA) and arrhythmia unless it is controlled by treatment, except for premature or disorders Mild driving.
• •18. Concurrent medical disorder, uncontrolled and important, such as kidney disease, liver, digestive, endocrine, pulmonary, neurological, brain, psychiatric, or which in the opinion of the investigator may represent a risk to the patient
• •19. Pregnancy or breastfeeding
• •20. Women of childbearing potential, including those whose last menstrual period was one year prior to screening.
• •21. Men unable or unwilling to use contraception
• •22. Patients with hypersensitivity to fludarabine, melphalan, thiotepa, tacrolimus, sirolimus and / or any excipients.