Humoral Immunodeficiency With Rituximab and Therapy With Subcutaneous Ig
| Status: | Active, not recruiting |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/21/2018 |
| Start Date: | July 21, 2017 |
| End Date: | June 2019 |
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
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.
(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.
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.
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.
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
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