IVIG for Infection Prevention After CAR-T-Cell Therapy
Start Date
6/10/2024
Completion Date
7/31/2028
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.
Detailed Description
OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive immunoglobulin replacement therapy (IGRT) with intravenous immune globulin (IVIG) within 14 days prior to CD19 CAR-T-cell infusion. Patients then undergo CD19 CAR-T therapy. Patients receive IVIG monthly, starting 28 days after CD19 CAR-T therapy for up to 4 months in the absence of unacceptable toxicity, relapse of the underlying disease, or subsequent hematopoietic cell transplant. Doses 3, 4, and 5 are highly encouraged but not required. Patients also undergo blood sample collection throughout the study. ARM II: Patients receive placebo with normal saline IV within 14 days prior to CD19 CAR-T treatment. Patients then undergo CD19 CAR-T-cell infusion. Patients receive normal saline monthly, starting 28 days after CD19 CAR-T therapy for up to 4 months in the absence of unacceptable toxicity, relapse of the underlying disease, or subsequent hematopoietic cell transplant. Doses 3, 4, and 5 are highly encouraged but not required. Patients also undergo blood sample collection throughout the study. After completion of study treatment, patients are followed up monthly through up to 6 months after CD19 CAR-T-cell infusion.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Immune Globulin Infusion (Human), 10% Solution
Anti-CD19 CAR T Cells Preparation
Saline
Biospecimen Collection
Survey Administration
Electronic Health Record Review
Conditions
Locations
City of Hope Cancer Center
Duarte, California 91010
United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida 33136
United States
Moffitt Cancer Center
Tampa, Florida 33612
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts 02114
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Oregon Health and Science University (OHSU) Knight Cancer Institute
Portland, Oregon 97239
United States
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington 98109
United States