Humoral Immunodeficiency in CLL and Therapy With Subcutaneous Ig

Rochester General Hospital

Status and phase

Completed

Phase 3

Phase 2

Conditions

Secondary Immune Deficiency Disorder

Treatments

Drug: Hizentra

Study type

Interventional

Funder types

Other

Identifiers

NCT03730129

CIC1850-A-18

Details and patient eligibility

About

Patients with chronic lymphocytic leukemia (CLL) are at increased risk of infections as compared to age matched controls, with infections being a major cause of morbidity and mortality. Previous studies have shown that patients with CLL have both hypogammaglobinemia and impaired humoral immunity as defined by vaccine responses to both polysaccharide and peptide antigens. Attempts at decreasing infections in CLL have included therapy with prophylactic antibiotics and intravenous immunoglobulin. In general clinical practice and in previous studies, patients have started IV immunoglobulin replacement therapy if they have a history of serious infection or hypogammaglobinemia (defined as Immunoglobulin G below 500-600 g/dL), but vaccine responses have not been evaluated. This study will identify CLL patients with humoral immunodeficiency by checking both Ig levels and vaccines responses. In patients with impaired humoral immunity, the investigators will use subcutaneous immunoglobulin replacement to show this intervention will increase Ig levels, protective antibody titers, and be well tolerated.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of chronic lymphocytic leukemia
Medically stable, with expected survival of > 1 year
Able to understand and willingness to sign a written informed consent
Able to comply with study procedures

Exclusion criteria

Previously diagnosed primary immunodeficiency
Additional immunosuppressive states as assessed by the primary or co investigators
Ongoing therapy with Ig replacement
Serum IgG < 500 mg/dL