B Cell Induction in Pediatric Lung Transplantation

Exclusion Criteria

• •Enrollment:
• •1. Inability or unwillingness of a participant to give written informed consent or comply with study protocol;
• •2. Multi-organ transplant;
• •3. Previous treatment with rituximab (Rituxan®);
• •4. History of severe allergic anaphylactic reactions to humanized or murine monoclonal antibodies;
• •5. History of severe reaction to previous therapy with intravenous immunoglobulin (IVIG);
• •6. History of Burkholderia cenocepacia;
• •7. History of anti-CD20 therapy;
• •8. Persistent hypogammaglobulinemia (IgG \< lower level of normal for age based on local laboratory ranges or 400 gm/dL for \>2 months) and/or IVIG replacement therapy;
• •9. Positive blood culture, sepsis or other disease process with hemodynamic instability at time of enrollment;
• •10. Any history of serologic positivity to HIV, HBsAg, HBcAb and HCV Ab;
• •11. History of malignancy less than 2 years in remission of malignancy (any history of adequately treated in-situ cervical carcinoma, or adequately treated basal or squamous cell carcinoma of the skin will be permitted);
• •12. Any condition, including psychiatric disorders, that in the opinion of the investigator would interfere with the subject's ability to comply with study requirements;
• •13. Participation in another investigational trial within 4 weeks of enrollment;
• •14. Currently lactating or plans to become pregnant during the timeframe of the study follow-up period;
• •15. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
• •Randomization:
• •1. Use of an induction agent other than Thymoglobulin®;
• •2. Renal insufficiency requiring hemodialysis or ultrafiltration;
• •3. Inability to obtain intravenous access;
• •4. Positive blood culture, sepsis or other disease process with hemodynamic instability at time of transplant;
• •5. Use of investigational agent(s) within 5 half-lives of the investigational drug or 4 weeks, whichever is longer;
• •6. Receipt of a MMR vaccine within 30 days prior to randomization;
• •7. Any condition that, in the opinion of the investigator, would interfere with the subject's ability to comply with study requirements.