Immunoglobulin Replacement Therapy and Infectious Complications After CD19-Targeted CAR-T-Cell Therapy
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.
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. Patients also undergo blood sample collection throughout the study. ARM II: Patients receive placebo with normal saline IV within 14 days…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent * For patients with medical incapacity or impaired consciousness such that they are not able to give fully informed voluntary consent, the subjects' legal representative must sign an institutional review board (IRB) approved informed consent document prior to the initiation of any screening or study-specific procedures * Participants must be 18 years of age or older * Participants will receive an Food and Drug Administration (FDA)-app…
Interventions
- BiologicalImmune Globulin Infusion (Human), 10% Solution
Given IV
- BiologicalAnti-CD19 CAR T Cells Preparation
Given CAR-T treatment
- OtherSaline
Given IV
- ProcedureBiospecimen Collection
Undergo blood sample collection
- OtherSurvey Administration
Ancillary studies
- OtherElectronic Health Record Review
Ancillary studies
Locations (7)
- City of Hope Cancer CenterDuarte, California
- University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, Florida
- Moffitt Cancer CenterTampa, Florida
- Massachusetts General Hospital Cancer CenterBoston, Massachusetts
- Memorial Sloan Kettering Cancer CenterNew York, New York
- Oregon Health and Science University (OHSU) Knight Cancer InstitutePortland, Oregon