Humoral Immunodeficiency With Rituximab and Therapy With Subcutaneous Ig

Rochester General Hospital

Status and phase: Completed; Phase 3; Phase 2

Conditions: Secondary Immune Deficiency

Treatments: Drug: 20% subcutaneous immunoglobulin

Study type: Interventional

Funder types: Other

Identifiers

NCT03211065

BT16-34083

Details and patient eligibility

About

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.

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of B cell non-Hodgkin's lymphoma
2. Medically stable
3. Able to understand and willingness to sign a written informed consent
4. Able to comply with study procedures

Exclusion criteria

1. Previously diagnosed primary immunodeficiency
2. Additional immunosuppressive states
3. Ongoing therapy with Ig replacement

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Immunoglobulin therapy

Experimental group

Description:

Patients with abnormal humoral function following treatment with rituximab will be treated with 20% subcutaneous immunoglobulin.

Treatment:

Drug: 20% subcutaneous immunoglobulin