NCT02266888

B Cell Induction in Pediatric Lung Transplantation

B Cell Targeted Induction to Improve Outcomes in Pediatric Lung Transplantation (CTOTC-08)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Patients who receive a lung transplant are at risk for rejection of the transplanted lung(s). Rejection occurs when the new lung triggers the body's defense (immune) system. When the immune system is triggered special cells are sent out to destroy the new lung and eventually the lung may not be able to function as it should. These special cells include B cells. B cells are an important part of the immune system and help the body fight infection. One way B cells fight infection is by producing antibodies. B cells and the antibodies they produce are involved in some kinds of rejection after organ transplantation.

Conditions

• Lung Transplant

Interventions

Type	Name	Description
BIOLOGICAL	Rituximab (Rituxan®)	2 Doses: 375 mg/m\^2 on Day 0 (within 12 hours of return to ICU following transplant) and Day 12 (+/-2 days).
BIOLOGICAL	Placebo	Placebo for Rituximab (Rituxan®). 2 Doses: 375 mg/m\^2 on Day 0 (within 12 hours of return to ICU following transplant) and Day 12 (+/-2 days).

Timeline

• Start date: 2015-01-22
• Primary completion: 2019-06-30
• Completion: 2019-06-30
• First posted: 2014-10-17
• Last updated: 2021-10-26
• Results posted: 2020-07-16

Locations

7 sites across 1 country: United States