A Phase 2/3 interventional study of 20% subcutaneous immunoglobulin in Secondary Immune Deficiency, sponsored by Rochester General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-19.
Sponsored by Rochester General Hospital · Phase 2/3, Interventional, and Treatment
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.
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.
698 studies on the registry are indexed under Immunologic Deficiency Syndromes; 67 are open to participants now.
This study's enrollment of 16 is below the median of 56 across 455 interventional studies indexed under Immunologic Deficiency Syndromes.
Browse Immunologic Deficiency Syndromes studies →Rochester General Hospital is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with abnormal humoral function following treatment with rituximab will be treated with 20% subcutaneous immunoglobulin.
Drug: 20% subcutaneous immunoglobulin
Subcutaneous Immunoglobulin
Also known as: Cuvitru
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
Time frame: 1 year
Quality of life score for participants during the one year enrollment
Assessed with Short Form 36 (SF 36)
Time frame: 1 year
Plan to share: No
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Immunologic Deficiency Syndromes→
Rochester General Hospital