Humoral Immunodeficiency With Rituximab and Therapy With Subcutaneous Ig

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03211065

Enrollment

Registered

2017-07-07

Start date

2017-07-21

Completion date

2019-11-01

Last updated

2021-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secondary Immune Deficiency

Keywords

Rituximab, Non Hodgkin's Lymphoma, Subcutaneous Immunoglobulin

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.

Interventions

DRUG20% subcutaneous immunoglobulin

Subcutaneous Immunoglobulin

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026