Major Program
Supportive Care and Symptom Management
Sponsor
Fred Hutchinson Cancer Center
Status
Recruiting
ClinicalTrials.gov ID
For more information, see ClinicalTrials.gov NCT05952804
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 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.
Intervention
Anti-CD19 CAR T Cells Preparation, Biospecimen Collection, Electronic Health Record Review, Immune Globulin Infusion (Human), 10% Solution, Saline, Survey Administration
Condition
Lymphoma
Investigators
Joshua Hill, MD, Frederick Locke, MD, Matthew Frigault, MD, Sanjeet Dadwal, MD, Miguel-Angel Perales, MD