Clinical trial NCT03211065: Humoral Immunodeficiency With Rituximab and Therapy With Subcutaneous Ig
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Secondary Immune Deficiency
Keywords: Rituximab
Non Hodgkin's Lymphoma
Subcutaneous Immunoglobulin
Lead sponsor: Rochester General Hospital
Sponsor class: OTHER
First posted: 2017-07-07
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of non-neutropenic infections per subject requiring antibiotics in the year after enrollment
timeFrame: 1 year
Secondary outcomes:
measure: Quality of life score for participants during the one year enrollment
timeFrame: 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Allergy and Immunology, 222 Alexander Street
state: New York
Study officials:
affiliation: Rochester Regional Health
name: S Shahzad Mustafa, MD
role: PRINCIPAL_INVESTIGATOR
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