Chronic Lymphocytic Leukemia Clinical Trial

Humoral Immunodeficiency in CLL and Therapy With Subcutaneous Ig

Summary

Patients with leukemia-cll/" >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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Eligibility Criteria

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

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 2

Estimated Enrollment:

20

Study ID:

NCT03730129

Recruitment Status:

Completed

Sponsor:

Rochester General Hospital

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There is 1 Location for this study

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Allergy, Immunology, Rheumatology at Rochester Regional Health
Rochester New York, 14607, United States

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 2

Estimated Enrollment:

20

Study ID:

NCT03730129

Recruitment Status:

Completed

Sponsor:


Rochester General Hospital

How clear is this clinincal trial information?

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