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Completed

NCT Number: NCT03211065

Humoral Immunodeficiency With Rituximab and Therapy With Subcutaneous Ig

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.

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Key information

Conditions

Secondary Immune Deficiency Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Allergy and Immunology, 222 Alexander Street

Rochester, New York, 14607, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of B cell non-Hodgkin's lymphoma
  • Medically stable
  • Able to understand and willingness to sign a written informed consent
  • Able to comply with study procedures

Exclusion criteria

  • Previously diagnosed primary immunodeficiency
  • Additional immunosuppressive states
  • Ongoing therapy with Ig replacement

Treatment and study plan

20% subcutaneous immunoglobulin

Drug

Subcutaneous Immunoglobulin

Other names: Cuvitru

Primary outcomes

  1. Number of non-neutropenic infections per subject requiring antibiotics in the year after enrollment

    Time frame: 1 year

    How many antibiotics are prescribed in one year for any type of infection

Secondary outcomes

  1. Quality of life score for participants during the one year enrollment

    Time frame: 1 year

    Assessed with Short Form 36 (SF 36)

Sponsors and collaborators

Lead sponsor

Rochester General Hospital

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 7, 2017
Registry last updated
Apr 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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