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IVIG for Infection Prevention After CAR-T-Cell Therapy
Sponsor: Fred Hutchinson Cancer Center
Summary
This phase II trial compares the effects of immunoglobulin replacement therapy with a placebo for preventing infectious complications in patients receiving CD19 chimeric antigen receptor (CAR)-T cell therapy. Hypogammaglobulinemia is a common complication in patients who receive CD19 CAR-T cell therapy. This is a condition in which the level of immunoglobulins (antibodies) in the blood is low and the risk of infection is high. Immunoglobulin replacement therapy works by replacing the body's immunoglobulin G (IgG) antibodies with donor blood product derived IgG antibodies that may help prevent infection. IgG antibodies are often depleted as a result of CAR-T therapy. Giving immunoglobulin replacement therapy may prevent infectious complications in patients receiving CD19 CAR-T cell therapy.
Official title: Immunoglobulin Replacement Therapy and Infectious Complications After CD19-Targeted CAR-T-Cell Therapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2024-06-10
Completion Date
2028-07-31
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
Immune Globulin Infusion (Human), 10% Solution
Given IV
Anti-CD19 CAR T Cells Preparation
Given CAR-T treatment
Saline
Given IV
Biospecimen Collection
Undergo blood sample collection
Survey Administration
Ancillary studies
Electronic Health Record Review
Ancillary studies
Locations (7)
City of Hope Cancer Center
Duarte, California, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Oregon Health and Science University (OHSU) Knight Cancer Institute
Portland, Oregon, United States
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States