Humoral Immunodeficiency With Rituximab and Therapy With Subcutaneous Ig

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Use of 20% Subcutaneous Immunoglobulin Replacement Therapy in Patients With B Cell Non Hodgkin's Lymphoma With Humoral Immune Dysfunction After Treatment With Rituximab

Conditions
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Secondary Immune Deficiency

Intervention / Treatment
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* Drug: 20% subcutaneous immunoglobulin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immunoglobulin therapy<br>Patients with abnormal humoral function following treatment with rituximab will be treated with 20% subcutaneous immunoglobulin. | Drug: 20% subcutaneous immunoglobulin<br>* Subcutaneous Immunoglobulin<br>* Other names: Cuvitru;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of non-neutropenic infections per subject requiring antibiotics in the year after enrollment | How many antibiotics are prescribed in one year for any type of infection | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life score for participants during the one year enrollment | Assessed with Short Form 36 (SF 36) | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rituximab, Non Hodgkin's Lymphoma, Subcutaneous Immunoglobulin