Allergy, Immunology, Rheumatology at Rochester Regional Health
Rochester, New York, 14607, United States
NCT Number: NCT03730129
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 2 / Phase 3
Rochester, New York, 14607, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will receive Hizentra 0.4 mg/kg qweekly subcutaneously for 6 months (24 weeks)
Time frame: 10 months
Incidence of humoral immunodeficiency
Time frame: 10 months
Effectiveness of Hizentra to change IgG levels
Time frame: 10 months
Effectiveness of Hizentra to change specific antibody titers in CLL
Time frame: 10 months
Safety and tolerability of Hizentra in CLL
Time frame: 10 months
Does Hizentra change quality of life scores in patients with CLL
Time frame: 10 months
Does Hizentra change the rate of non-neutropenic infections in CLL
Rochester General Hospital
Other
A Prospective Case Series of Subcutaneous Immunoglobulin for Prophylaxis of Infections in Patients With Chronic Lymphocytic Leukemia With Impaired Humoral Immunity
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