Non Hodgkin Lymphoma Clinical Trial

Humoral Immunodeficiency With Rituximab and Therapy With Subcutaneous Ig

Summary

To study the use of subcutaneous (injected under the skin) immunoglobulin replacement therapy (replacement of antibodies, which are infection-fighting proteins) in patients with a type of blood cancer called lymphoma, who have been treated with rituximab (a type of chemotherapy) and have an abnormal immune system putting them at increased risk of infection.

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Full Description

The investigators propose evaluating patients with B cell non-Hodgkin's lymphoma treated with rituximab within the past 2 years with baseline immunoglobulin levels and vaccine responses to polysaccharide (pneumococcus, meningococcus) and peptide (tetanus, diphtheria) antigens. Patients with impaired vaccine responses may benefit most from immunoglobulin prophylaxis and will be proactively started on 20% subcutaneous replacement therapy. This study is novel in that it will stratify patients according to their humoral response to polysaccharide and peptide vaccines, and will proactively initiate therapy with the new 20% subcutaneous immunoglobulin in those with impaired humoral response rather than starting it after infections occur. This will potentially lead to decreased infections and improved quality of life.

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Eligibility Criteria

Inclusion Criteria:

Diagnosis of B cell non-Hodgkin's lymphoma
Medically stable
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
Ongoing therapy with Ig replacement

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

16

Study ID:

NCT03211065

Recruitment Status:

Completed

Sponsor:

Rochester General Hospital

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There is 1 Location for this study

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Allergy and Immunology, 222 Alexander Street
Rochester New York, 14607, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

16

Study ID:

NCT03211065

Recruitment Status:

Completed

Sponsor:


Rochester General Hospital

How clear is this clinincal trial information?

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