Tocilizumab in Lung Transplantation

Exclusion Criteria57

• Study Entry:
• Listed for multi-organ transplant (e.g., heart-lung, liver-lung, kidney-lung)
• Prior history of allogeneic organ or cellular transplantation
• Received treatment to deplete Human Leukocyte Antigens (HLA) antibodies before transplantation
• Currently breast-feeding a child or plans to become pregnant during the timeframe of the study follow up period
• History of severe allergic and/or anaphylactic reactions to humanized or murine monoclonal antibodies
• Known hypersensitivity or previous treatment with ACTEMRA(R) (tocilizumab) within the last 3 months
• Infection with human immunodeficiency virus (HIV)
• Hepatitis B virus surface antigen or core antibody positive
• Hepatitis C virus PCR positive (HCV+) patients who have failed to demonstrate sustained viral remission (2 consecutive PCR or Nucleic Acid Tests (NAT) negative tests at least 24 weeks apart), with or without anti-viral treatment;
• Chronic infection with Burkholderia cenocepacia or Burkholderia gladioli
• Non-tuberculous mycobacterial (NTM) pulmonary disease; if there is a history of NTM pulmonary disease, culture conversion is necessary for eligibility
• Presence of active malignancy or history of malignancy less than 5 years in remission, excluding adequately treated in-situ cervical carcinoma, low grade prostate carcinoma, or adequately treated basal or squamous cell carcinoma of the skin
• History of hemolytic-uremic syndrome/ thrombotic thrombocytopenia purpura
• History of demyelinating disorders (e.g., multiple sclerosis, chronic inflammation demyelinating polyneuropathy)
• Current treatment with alkylating agents such as cyclophosphamide
• History of gastrointestinal (GI) tract perforation
• History of inflammatory bowel disease except fully excised ulcerative colitis
• Any history of diverticulitis (event if not perforated) or confirmed diverticular bleeding. (Diverticulosis is not an exclusion).
• Patients with a platelet count \< 100,000/mm\^3 (last measurement within 7 days prior to enrollment)
• Patients with an absolute neutrophil count (ANC) \< 2,000/mm\^3 (last measurement within 7 days prior to enrollment)
• Patients with Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) levels \>3 times upper limit of normal
• Patients who use illegal drugs
• Smoking or vaping within 6 months of listing for transplant
• Use of investigational drugs within 4 weeks prior to enrollment
• Any condition that in the opinion of the site Principal Investigator (PI) introduces undue risk by participating in this study
• Randomization:
• Recipient of multi-organ or tissue transplants
• Clinically stable, without clinical evidence of untreated infection
• Received a live virus vaccine within 30 days prior to randomization
• Received treatment to deplete HLA antibodies before transplantation to improve the possibility of transplantation
• Patients with known donor-specific antibody that will require intervention based on local clinical protocols
• History of GI tract perforation
• History of inflammatory bowel disease except fully excised ulcerative colitis
• History of diverticulitis (diverticulosis is not an exclusion) or diverticular bleeding
• History of severe allergic anaphylactic reactions to humanized or murine monoclonal antibodies
• Known hypersensitivity to ACTEMRA® (tocilizumab)
• Previous treatment with ACTEMRA® (tocilizumab) within the last 3 months.
• Recipient or donor with infection with human immunodeficiency virus (HIV)
• Recipient with hepatitis B virus surface antigen or hepatitis B core antibody positive
• Hepatitis B negative transplant recipient that received a transplant from a Hepatitis B core antibody positive donor unless the recipient has a Hepatitis B Surface Antigen (HBsAb) titer \>10U/L
• Recipient of a hepatitis C virus nucleic acid test (NAT) positive donor organ
• Latent TB infection (LTBI) and has not completed appropriate therapy
• Chronic infection with Burkholderia cenocepacia or Burkholderia gladioli
• Non-tuberculous mycobacterial (NTM) pulmonary disease; if there is a history of NTM pulmonary disease, culture conversion is necessary for eligibility
• Presence of active malignancy (except for non-melanoma skin cancer)
• History of hemolytic-uremic syndrome/ thrombotic thrombocytopenia purpura
• History of demyelinating disorders (e.g., multiple sclerosis, chronic inflammation demyelinating polyneuropathy)
• Current treatment with alkylating agents such as cyclophosphamide
• Patients with AST or ALT levels \> 1.5 times upper limit of normal (last measurement within 1 day prior to randomization)
• Patients with platelet count \<100,000/mm\^3 (last measurement within 1 day prior to randomization)
• Patients with an absolute neutrophil count (ANC) \<2,000/mm\^3 (last measurement within 1 day prior to randomization)
• Patients who are administered anti-thymocyte globulin as induction therapy in the immediate post- transplant period
• Patients who have been treated in the past 3 months, or for whom it is anticipated that treatment with any immunomodulatory biological agents post-transplant are excluded
• Use of an investigational drug after transplant
• Smoking or vaping since enrollment
• Any condition that in the opinion of the site PI introduces undue risk by participating in this study