B Cell Targeted Induction to Improve Outcomes in Pediatric Lung Transplantation (CTOTC-08)
In this study, doctors are trying to see if a study drug called rituximab (Rituxan®) will lower the number of B cells in the body. Doctors are also trying to see if decreasing B cells with rituximab (Rituxan®) can prevent injury to the transplanted lung. This treatment has been studied in other types of solid organ transplants.
• Subject and/or parent guardian must be able to understand and provide informed consent;
• Candidate for a primary lung transplant (listed for lung transplant);
• Female and male subjects with reproductive potential must agree to use FDA approved methods of birth control for 12-months after completion of treatment.
• Adequate bone marrow functions based on the following criteria:
• Absolute neutrophil count (ANC): >1000mm^3
• Platelets: >100,000/mm^3
• Hemoglobin: >7 gm/dL
• AST or ALT< 2x Upper Limit of Normal unless related to primary disease
• Individuals who meet all of the following criteria are eligible for randomization:
• Serum IgG immunoglobulin level greater than lower level of normal for age based on local laboratory ranges or 400mg/dL within 90 days prior to randomization;
• Female subjects of childbearing potential must have a negative pregnancy test within 4 hours of transplant;
• Negative for Hepatitis B infection (if at time of transplant, participant does not exhibit effective immunization, the participant should be re-tested).