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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Subjects will receive Hizentra 0.4 mg/kg qweekly subcutaneously for 6 months (24 weeks)
Allergy, Immunology, Rheumatology at Rochester Regional Health
Rochester, New York, United States
Identify patients with CLL with humoral immunodeficiency despite serum IgG > 500 mg/dL.
Incidence of humoral immunodeficiency
Time frame: 10 months
Number of patients who increase IgG to above 700 mg/dL
Effectiveness of Hizentra to change IgG levels
Time frame: 10 months
Number of patients who increase diphtheria IgG to above 0.1 IU/mL, tetanus IgG to above 0.1 IU/mL, and IgG to streptococcus pneumonia to above 1.3 mcg/mL
Effectiveness of Hizentra to change specific antibody titers in CLL
Time frame: 10 months
Number of subjects with treatment-related adverse effects as assessed by CTCAE v4.0
Safety and tolerability of Hizentra in CLL
Time frame: 10 months
Quality of life (Short Form 36) on subcutaneous Ig replacement therapy a 0-100 scale, with lower scores indicating higher disability/lower quality of life
Does Hizentra change quality of life scores in patients with CLL
Time frame: 10 months
Track the number of infections requiring antibiotics, further characterized per severity as defined in previous studies
Does Hizentra change the rate of non-neutropenic infections in CLL
Time frame: 10 months
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