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

Status: Completed
Location: See all (7) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 21
Healthy Volunteers: No
View:

• Enrollment:

• 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

• Randomization:

• 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).

Locations
United States
California
Stanford University
Palo Alto
Massachusetts
Children's Hospital Boston
Boston
Missouri
Washington University
Saint Louis
Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati
Nationwide Children's Hospital
Columbus
Pennsylvania
Children's Hospital of Philadelphia
Philadelphia
Texas
Texas Children's Hospital
Houston
Time Frame
Start Date: January 22, 2015
Completion Date: June 30, 2019
Participants
Target number of participants: 45
Treatments
Experimental: Rituximab Induction
Rituximab (Rituxan®) Induction Therapy Plus Standard of Care Immunosuppression (thymoglobulin induction, tacrolimus or equivalent, mycophenolate mofetil (MMF) or equivalent, and steroids)
Placebo Comparator: Placebo Induction
Placebo Induction Therapy Plus Standard of Care Immunosuppression (Thymoglobulin® induction, tacrolimus or equivalent, mycophenolate mofetil (MMF) or equivalent, and steroids)
Related Therapeutic Areas
Sponsors
Collaborators: Clinical Trials in Organ Transplantation in Children, Rho Federal Systems Division, Inc.
Leads: National Institute of Allergy and Infectious Diseases (NIAID)

This content was sourced from clinicaltrials.gov

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