IVIG for Infection Prevention After CAR-T-Cell Therapy - Trial NCT05952804
Access comprehensive clinical trial information for NCT05952804 through Pure Global AI's free database. This Phase 2 trial is sponsored by Fred Hutchinson Cancer Center and is currently Not yet recruiting. The study focuses on Lymphoma. Target enrollment is 150 participants.
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Study Focus
Sponsor & Location
Fred Hutchinson Cancer Center
Timeline & Enrollment
Phase 2
Dec 01, 2023
Jul 31, 2028
Primary Outcome
Incidence rate of serious bacterial infections in the modified intention-to-treat (mITT) population
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 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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05952804
Non-Device Trial