Chimeric antigen receptor (CAR) T cells are special immune cells taken from a patient and changed in a lab to help them find and attack cancer cells. These cells are designed to look for a marker called CD19, which is found on both cancer cells and healthy B cells (a type of white blood cell). Because of this, CAR T cells can also destroy healthy B cells. This can lead to a strong drop in B cells and cause a condition called hypogammaglobulinemia (HGG), which makes it harder for the body to fight infections. Serious infections are common in people treated with CAR T cells and are a major reason for death that is not caused by the return of cancer. To help prevent infections, patients with HGG often get immunoglobulin replacement therapy (IRT), which gives them the antibodies they need. This treatment can be given through a vein (IVIG) or under the skin (SCIG). The goal of this project is to study how often these patients get bacterial infections, how they feel about their quality of life and treatment, and what side effects they may have when treated with IVIG or SCIG after CAR T-cell therapy.
Chimeric antigen receptor (CAR) T cells are patient-derived T cells engineered to express a fusion protein that directs them to target a tumor-associated antigen. The tumor-associated antigen CD19 is expressed on tumor cells in these conditions as well as on healthy cells of the B cell lineage. This results the "on-target off-tumor" effect of profound B cell depletion in these patients often with attendant hypogammaglobulinemia (HGG). Serious infections are common in this patient population and represent the main cause of non-relapse related mortality in CAR T cell treated patients. Treatment of HGG with immunoglobulin replacement therapy (IRT) is a core component of infection prevention. Standard of care IRT can be administered intravenously (IVIG) or subcutaneously (SCIG). The proposed project will investigate frequency of bacterial infections, quality of life, treatment satisfaction, and adverse events in patients treated with CAR T-cell therapy who are treated with IVIG and SCIG.
Study Type
OBSERVATIONAL
Enrollment
30
Intravenous immune globulin replacement
Subcutaneous immune globulin replacement
University of Alberta
Edmonton, Alberta, Canada
RECRUITINGTime normalized rate of infections grade 3 or greater
Time normalized rate of infections grade 3 or greater
Time frame: 40 weeks
Time normalized rate of validated infections
Time normalized rate of infections (per subject-year) confirmed using microbiologic, clinical, and radiologic criteria
Time frame: 40 weeks
Days on therapeutic antibiotics
Days on therapeutic antibiotics for treatment of an infection (excluding days on routinely provided prophylactic antibiotics)
Time frame: 40 weeks
Days missed work/school/unable to perform normal daily activities due to infections
Days missed work/school/unable to perform normal daily activities due to infections (rate per subject-year)
Time frame: 40 weeks
Total number of days of hospitalizations due to infections
Total number of days of hospitalizations due to infections (rate per subject-year)
Time frame: 40 weeks
Geometric mean of IgG serum trough concentration
Geometric mean of IgG serum trough concentration at last study visit
Time frame: 40 weeks
Mean TSQM9
Treatment Satisfaction Questionnaire for Medication (TSQM9)
Time frame: 40 weeks
IRT-related adverse events
Nature and frequency of immune globulin-related adverse events
Time frame: 40 weeks
Hours of infusion clinic time required for IVIG administration
Hours of infusion clinic time required for IVIG administration
Time frame: 40 weeks
Mean total grams of immunoglobulin administered
Mean total grams of immunoglobulin administered per patient-year
Time frame: 40 weeks
Mean leukocyte counts at the last study visit
Mean leukocyte counts at the last study visit
Time frame: 40 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.