Humoral Immunodeficiency With Rituximab and Therapy With Subcutaneous Ig

Phase 2

Completed

• Conditions: Secondary Immune Deficiency
• Interventions: Drug: 20% subcutaneous immunoglobulin

• Registration Number: NCT03211065
• Lead Sponsor: Rochester General Hospital

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.

Study Timeline

• Study First Submitted: 2017-07-03
• Study First Submitted QC: 2017-07-05
• Study First Posted: 2017-07-07
• Study Start: 2017-07-21
• Primary Completion: 2019-11-01
• Study Completion: 2019-11-01
• Status Verified: 2020-08
• Last Update Submitted: 2021-04-14
• Last Update Posted: 2021-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Immunoglobulin therapy	20% subcutaneous immunoglobulin	Patients with abnormal humoral function following treatment with rituximab will be treated with 20% subcutaneous immunoglobulin.

Primary Outcome Measures

Name	Time	Method
Number of non-neutropenic infections per subject requiring antibiotics in the year after enrollment	1 year	How many antibiotics are prescribed in one year for any type of infection

Secondary Outcome Measures

Name	Time	Method
Quality of life score for participants during the one year enrollment	1 year	Assessed with Short Form 36 (SF 36)

Trial Locations

Locations (1)

Allergy and Immunology, 222 Alexander Street; 🇺🇸 Rochester, New York, United States